INDICATIONS, SAFETY, AND WARNINGS Titan Endoskeleton™ Anterolateral Products

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ENDOSKELETON™ TL INTERBODY FUSION IMPLANTS

DESCRIPTION

The Endoskeleton TL Interbody Fusion Device implants are available in a variety of lengths, widths, and heights for treatment in Lateral Lumbar Interbody Fusion and are designed with a large hollow region in the center to house autograft bone, allograft bone comprised of  cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. The new bone formation through the implant is intended to provide long-term structural support and fusion at the implanted disc space. The design incorporates “windows” through the implant to permit visualization of the graft material and over time formation of new bone.  The superior and inferior surfaces include either the Chemtex™ surface  treatment or nanoLOCK surface treatment (MMN) designed to improve fixation to the adjacent bone. The nanoLOCK surface technology (MMN) provides a microscopic roughened surface with nano-scale features.  The implants are composed of ASTM F136 Ti 6Al-4V ELI titanium alloy  and provided either sterile or non-sterile.

An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant inserter and to facilitate placement of the implant into the interbody space.

INDICATION FOR USE

The Endoskeleton TL Interbody Fusion Device is indicated for use in spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients with  previous non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or  demineralized allograft bone with bone marrow aspirate. 

WARNINGS

In using metallic implants, the surgeon should be aware of the following:

  1. The correct selection of the implant is extremely important. The potential for success is increased by the selection of the proper size, shape and design of the implant.
  2. The surgeon must ensure that all necessary implants and instruments are on hand prior to surgery. An adequate inventory of implant sizes should be available at the time of surgery, including sizes larger and  smaller than those expected to be used.
  3. The correct handling of the implants is extremely important. Contouring of the implants is to be avoided.
  4. The Titan Spine Endoskeleton TL Interbody Fusion Device has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of Endoskeleton TL Interbody Fusion Device in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

CONTRAINDICATIONS

  1. As with all orthopedic implants, the Endoskeleton TL Interbody Fusion Device should never be reused under any circumstances. Reuse may result in but is not limited to the following; infection  or bending, loosening or breakage due to impairment of  implant integrity.
  2. The Endoskeleton TL Interbody Fusion Device should never be implanted in patients with a systemic or local infection.
  3. The Endoskeleton TL Interbody Fusion Device should not be used with components of any other interbody systems. The device must be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine.
  4. The Endoskeleton TL Interbody Fusion device should not be  implanted in patients with an allergy to titanium or titanium alloys.
  5. All patients should have at least 6 months of non-operative care prior to spinal fusion with the Endoskeleton TL Interbody  Fusion device.
  6. The Endoskeleton TL Interbody Fusion Device should not be implanted in patients with a prior fusion at the level(s) to be treated.

PRECAUTIONS

Preoperative:

  1. Only patients that meet the criteria described in the indications should be selected.
  2. Based on fatigue testing results, when using the Endoskeleton TL Interbody Fusion Device, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system.
  3. Safety and effectiveness has not been established in patients  with the following conditions: morbid obesity; symptomatic  cardiac disease; pregnancy; signs of local inflammation; fever or leukocytosis; metal sensitivity/allergy to the implant materials;  any medical or surgical condition which would preclude the  potential benefit of spinal implant surgery, such as the elevation  of sedimentation rate unexplained by other diseases, elevation  of white blood count (WBC), or a marked left shift in the WBC  differential count; grossly distorted anatomy due to congenital abnormalities; osteopenia, and/or osteoporosis (osteoporosis is  a relative contraindication since this condition may limit the  obtainable correction, the amount of mechanical fixation, and/or the quality of the bone graft); long term systemic corticosteroid use; active drug abuse; any case requiring the mixing of metals from different components; any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition; any patient unwilling to cooperate with the postoperative instructions; any time implant utilization would interfere with anatomical structures or expected physiological performance. Patient conditions and/or predispositions such as these should be avoided. Other conditions may  exist where safety and effectiveness have not been established.
  4. Care should be used in handling and storage of the implants and instruments. The implants should not be scratched or otherwise damaged. Implants and instruments should be protected during storage especially from corrosive environments. Devices should be routinely inspected; if they exhibit wear, damage, corrosion,  or discoloration they should be returned to Titan Spine for further evaluation.
  5. The type of construct to be assembled for the case should be determined prior to beginning the surgery.
  6. Because mechanical parts are involved, the surgeon should be familiar with the various components before using the equipment and should personally assemble the implants to verify that all parts and necessary instruments are present before the surgery begins.
  7. Proper implant selection and patient compliance to postoperative precautions will greatly affect surgical outcomes. Patients who smoke have been shown to have an increased incidence of  nonunion. Therefore, these patients should be advised of this  fact and warned of the potential consequences. 
  8. Postoperative care is important. The patient should be instructed in the limitations of his/her metallic implant(s) and should be  cautioned regarding weight bearing and body stress on the  appliance prior to secure bone healing.

Intraoperative:

  1. Any instruction manuals should be carefully followed.
  2. At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to nerves may occur resulting in loss of neurological functions.
  3. The implant surfaces should not be scratched or notched since such actions may reduce the functional strength of the construct.
  4. Either autograft, cancellous and/or corticocancellous allograft, demineralized allograft with bone marrow aspirate or a combination thereof must be placed in the area to be fused and the graft must be in contact with viable bone.
  5. Internal and external threads on instruments can be damaged by cross-threading. Inspect internal and external threads for damage prior to assembly. If threads are damaged, set the product aside and do not use. When threading components together, keep to the thread axis. Screw in the component as far as it will go and make sure that the product is flush with the insertion instrument. On all threaded connections, finger tighten only.

Postoperative:

  1. The physician’s postoperative directions and warnings to the patient and corresponding patient compliance are extremely important.
  2. Detailed instructions on the use and limitations of the implant(s) should be given to the patient. If partial weight bearing is recommended or required prior to firm bony union, the patient must be warned that bending, loosening or breakage of the implant(s)  are complications which can occur as a result of excessive or  early weight bearing or excessive muscular activity. The risk of bending, loosening or breakage of an internal fixation device during postoperative rehabilitation may be increased if the patient is active or if the patient is debilitated, demented or otherwise unable to use crutches or other such weight supporting devices. The patient should be warned to avoid falls or sudden jolts in spinal position.
  3. To allow maximum chances for a successful surgical result, the  patient or implant(s) should not be exposed to mechanical  vibrations that may loosen the implant(s). The patient should be warned of this possibility and instructed to limit and restrict  physical activities, especially lifting, twisting motions and any type of sport participation. The patient should be advised not to smoke or consume alcohol during the bone graft healing process.
  4. The patient should be advised of their inability to bend at the point of spinal fusion and taught to compensate for this permanent  physical restriction on body motion.
  5. If a nonunion develops or if the implant(s) loosen, bend and/or break, the implant(s) should be revised and/or removed immediately before serious injury occurs. Failure to immobilize a delayed or  nonunion of bone will result in excessive and repeated stresses on the implant(s). By the mechanism of fatigue these stresses can cause eventual bending, loosening or breakage of the implant(s). It is important that immobilization of the spinal surgical site be  maintained until firm bony union is established and confirmed by roentgenographic examination. The patient must be adequately warned of these hazards and closely supervised to ensure cooperation until bony union is confirmed. 
  6. Any retrieved implants should be treated in such a manner that reuse in another surgical procedure is not possible. As with all orthopedic implants, none of the Endoskeleton TL Interbody Fusion Devices should ever be reused under any circumstances. Reuse may result in but is not limited to the following; infection or bending, loosening or breakage due to impairment of implant integrity.

ADVERSE EVENTS

Possible adverse effects include, but are not limited to, bending,  loosening, or fracture of the implants or instruments; loss of  fixation; sensitivity to a metallic foreign body, including possible tumor formation; skin or muscle sensitivity in patients with inadequate tissue coverage over the operative site, which may result in skin breakdown and/or wound complications; nonunion or delayed union; infection; nerve or vascular damage due to surgical trauma, including loss of neurological function, dural tears, radiculopathy, paralysis, and cerebral fluid leakage; gastrointestinal, urological and/or reproductive system compromise, including sterility, impotency, and/or loss of consortium; pain or discomfort; bone loss due to resorption or stress shielding, or bone fracture at, above, or below the level of surgery (fracture of the vertebra); hemorrhage of blood vessels and/or hematomas; malalignment of anatomical structures, including loss of proper spine curvature, correction, reduction, and/or height; bursitis; bone graft donor site pain; inability to resume activities of normal daily living; reoperation or death.

 

ENDOSKELETON™ TA INTERBODY FUSION DEVICE IMPLANTS

DESCRIPTION

The Endoskeleton TA Interbody Fusion Device implants are designed with a large hollow region in the center to house autograft bone, allograft bone comprised of cancellous and/ or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof. The new bone formation through the implant is intended to provide long-term structural support and fusion at the implanted disc space. The design incorporates “windows” through the implant to permit visualization of the graft material and over time formation of new bone. The superior and inferior surfaces include either the Chemtex™ surface treatment or nanoLOCK surface treatment (MMN) designed to improve fixation to the adjacent bone. The nanoLOCKsurface technology (MMN) provides a microscopic roughened surface with nano-scale features. The implants are composed of ASTM F136 Ti 6Al-4V ELI titanium alloy and provided either sterile or non-sterile.An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant holder, and to facilitate placement of the implant into the interbody space.

INDICATIONS FOR USE

The Endoskeleton TA Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device is intended to be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Endoskeleton TA is indicated to be used with autograft bone and/or allograft bone comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate or a combination thereof.

WARNINGS

In using metallic implants, the surgeon should be aware of the following:

  1. The correct selection of the implant is extremely important. The potential for success is increased by the selection of the proper size, shape and design of the implant.
  2. The surgeon must ensure that all necessary implants and instruments are on hand prior to surgery. An adequate inventory of implant sizes should be available at the time of surgery, including sizes larger and smaller than those expected to be used.
  3. The correct handling of the implants is extremely important. Contouring of the implants is to be avoided.
  4. The Titan Spine Endoskeleton TA Interbody Fusion Device has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifact in the MR environment. The safety of Endoskeleton TA Interbody Fusion Device in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

CONTRAINDICATIONS

  1. As with all orthopedic implants, the Endoskeleton TA Interbody Fusion Device should never be reused under any circumstances. Reuse may result in, but is not limited to the following; infection or bending, loosening or breakage due to impairment of implant integrity.
  2. The Endoskeleton TA Interbody Fusion Device should never be implanted in patients with a systemic or local infection.
  3. The Endoskeleton TA device should not be used with components of any other interbody systems. Supplemental fixation that has been cleared by the FDA for use in the lumbar spine may be used.
  4. The Endoskeleton TA device should not be implanted in patients with an allergy to titanium or titanium alloys.
  5. All patients should have at least 6 months of non-operative care prior to spinal fusion with the Endoskeleton TA device.
  6. The Endoskeleton TA Interbody Fusion Device should not be implanted in patients with a prior fusion at the level(s) to be treated.

PRECAUTIONS

Preoperative:

  1. Only patients that meet the criteria described in the indications should be selected.
  2. Based on fatigue testing results, when using the Endoskeleton TA Interbody Fusion Device, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system.
  3. Safety and effectiveness has not been established in patients with the following conditions: morbid obesity; symptomatic cardiac disease; pregnancy; signs of local inflammation; fever or leukocy-tosis; metal sensitivity/allergy to the implants materials; any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count; grossly distorted anatomy due to congenital abnormalities; osteopenia, and/or osteoporosis (osteoporosis is a relative contraindication since this condition may limit the obtainable correction, the amount of mechanical fixation, and /or the quality of the bone graft); long term systemic corticosteroid use; active drug abuse; any case requiring the mixing of metals from different components; any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition; any patient unwilling to cooperate with the postoperative instructions; any time implant utilization would interfere with ana-tomical structures or expected physiological performance. Patient conditions and/or predispositions such as these should be avoided. Other conditions may exist where safety and effectiveness have not been established.
  4. Care should be used in handling and storage of the implants and instruments. The implants should not be scratched or otherwise damaged. Implants and instruments should be protected during storage especially from corrosive environments. Devices should be routinely inspected; if they exhibit wear, damage, corrosion, or discoloration they should be returned to Titan Spine for further evaluation.
  5. The type of construct to be assembled for the case should be determined prior to beginning the surgery.
  6. Because mechanical parts are involved, the surgeon should be familiar with the various components before using the equipment and should personally assemble the implants to verify that all parts and necessary instruments are present before the surgery begins.
  7. Proper implant selection and patient compliance to postoperative precautions will greatly affect surgical outcomes. Patients who smoke have been shown to have an increased incidence of nonunion. Therefore, these patients should be advised of this fact and warned of the potential consequences.
  8. Postoperative care is important. The patient should be instructed in the limitations of his/her metallic implant(s) and should be cautioned regarding weight bearing and body stress on the appliance prior to secure bone healing. 

Intraoperative:

  1. Any instruction manuals should be carefully followed.
  2. At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to nerves may occur resulting in loss of neurological functions.
  3. The implant surfaces should not be scratched or notched since such actions may reduce the functional strength of the construct.
  4. Either autograft, cancellous and/or corticocancellous allograft, demineralized allograft with bone marrow aspirate or a combination thereof must be placed in the area to be fused and the graft must be in contact with viable bone.
  5. Internal and external threads on instruments can be damaged by cross-threading. Inspect internal and external threads for damage prior to assembly. If threads are damaged, set the product aside and do not use. When threading components together, keep to the thread axis. Screw in the component as far as it will go and make sure that the product is flush with the insertion instrument. On all threaded connections, finger tighten only.

Postoperative:

  1. The physician’s postoperative directions and warnings to the patient and corresponding patient compliance are extremely important.
  2. Detailed instructions on the use and limitations of the implant(s) should be given to the patient. If partial weight bearing is recom-mended or required prior to firm bony union, the patient must be warned that bending, loosening or breakage of the implant(s) are complications which can occur as a result of excessive or early weight bearing or excessive muscular activity. The risk of bending, loosening or breakage of an internal fixation device during postoper-ative rehabilitation may be increased if the patient is active or if the patient is debilitated, demented or otherwise unable to use crutches or other such weight supporting devices. The patient should be warned to avoid falls or sudden jolts in spinal position.
  3. To allow maximum chances for a successful surgical result, the patient or implant(s) should not be exposed to mechanical vibrations that may loosen the implant(s). The patient should be warned of this possibility and instructed to limit and restrict physical activities, especially lifting, twisting motions and any type of sport participation. The patient should be advised not to smoke or consume alcohol during the bone graft healing process.
  4. The patient should be advised of their inability to bend at the point of spinal fusion and taught to compensate for this permanent physical restriction on body motion.
  5. If a nonunion develops or if the implant(s) loosen, bend and /or break, the implant(s) should be revised and/or removed immediately before serious injury occurs. Failure to immobilize a delayed or non-union of bone will result in excessive and repeated stresses on the implant(s). By the mechanism of fatigue these stresses can cause eventual bending, loosening or breakage of the implant(s). It is important that immobilization of the spinal surgical site be maintained until firm bony union is established and confirmed by roentgenographic examination. The patient must be adequately warned of these hazards and closely supervised to ensure cooperation until bony union is confirmed.
  6. Any retrieved implants should be treated in such a manner that reuse in another surgical procedure is not possible. As with all orthopedic implants, none of the Endoskeleton TA Interbody Fusion implants should ever be reused under any circumstances. Reuse may result in, but is not limited to the following; infection or bending, loosening or breakage due to impairment of implant integrity.

ADVERSE EVENTS

Possible adverse effects include, but are not limited to, bending, loosening, or fracture of the implants or instruments; loss of fixation; sensitivity to a metallic foreign body, including possible tumor formation; skin or muscle sensitivity in patients with inadequate tissue coverage over the operative site, which may result in skin breakdown and/ or wound complications; nonunion or delayed union; infection; nerve or vascular damage due to surgical trauma, including loss of neurological function, dural tears, radiculopathy, paralysis, and cerebral fluid leakage; gastrointestinal, urological and/or reproductive system compromise, including sterility, impotency, and/or loss of consortium; pain or discomfort; bone loss due to resorption or stress shielding, or bone fracture at, above, or below the level of surgery (fracture of the vertebra); hemorrhage of blood vessels and/or hematomas; malalignment of anatomical structures, including loss of proper spine curvature, correction, reduction, and/or height; bursitis; bone graft donor site pain; inability to resume activities of normal daily living; reoperation or death.

 

ENDOSKELETON™ TAS AND ENDOSKELETON™ TAS HYPERLORDOTIC INTERBODY FUSION DEVICE IMPLANTS

DESCRIPTION

The ENDOSKELETON™ TAS and ENDOSKELETON™ TAS Hyperlordotic Interbody Fusion Device implants are available in a variety of Anterior Lumbar Interbody Fusion (ALIF) sizes with a variety of lordotic angles, to accommodate patient anatomy; Hyperlordotic implants are those defined by a lordotic angle ≥ 16˚ . Implants are designed with a large hollow region in the center to house autograft bone material. The new bone formation through the implant is intended to provide long-term structural support and fusion at the implanted disc space. The design incorporates “windows” through the implant to permit visualization of the graft material and over time formation of new bone. The superior and inferior surfaces include either the previously cleared Chemtex™ surface treatment or previously cleared nanoLOCK™ surface treatment to improve fixation to the adjacent bone. The nanoLOCK™ surface technology provides a microscopic roughened surface with nano-scale features. The implant system includes integrated fixation (screws) for stabilizing the implants when placed in the interbody space.

An implant holding feature has been incorporated into the trailing surface of the implant to mate with the implant holder, and to facilitate placement of the implant into the interbody space. Screws include internal hex drive features matched to instrumentation for implantation. All implantable components are manufactured from medical grade titanium alloy (Ti6A14V-ELI).

INDICATIONS FOR USE

The ENDOSKELETON™ TAS InterbodyFusionDeviceisindicatedfor useinskeletallymaturepatients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved l evel(s). Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device is a standalone system that is intended to be used with the bone screws provided and requires no additional supplementary fixation. The device is indicated to be used with autograft bone.

HYPERLORDIC DEVICES ≥16˚

The Endoskeleton™ TAS Hyperlordotic Interbody Fusion Device (≥ 16˚) is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device is indicated to be used with autograft bone. The Endoskeleton™ TAS Hyperlordotic Interbody Fusion Device must be used with a posterior supplemental internal spinal fixation that has been cleared by the FDA for use in the lumbar spine.

WARNINGS

WARNINGS: In using metallic implants, the surgeon should be aware of the following:

  1. As with all orthopedic implants, the ENDOSKELETON™ TAS or ENDOSKELETON™ TAS Hyperlordotic Interbody Fusion Devices should never be reused under any circumstances. Reuse may result in, but is not limited to the following; infection or bending, loosening or breakage due to impairment of implant integrity.
  2. The ENDOSKELETON™ TAS or ENDOSKELETON™ TAS Hyperlordotic Interbody Fusion Device should never be implanted in patients with a systemic or local infection.
  3. The ENDOSKELETON™ TAS or ENDOSKELETON™ TAS Hyperlordotic system should not be used with components of any other interbody systems.
  4. The Titan Spine ENDOSKELETON™ TAS or ENDOSKELETON™ TAS Hyperlordotic Interbody Fusion Systems have not been evaluated for safety and compatibility in the MR environment. Potential Risks in the MR environment may include; heating, migration, and image artifact.

CONTRAINDICATIONS

  1. As with all orthopedic implants, the ENDOSKELETON™ TAS or ENDOSKELETON™ TAS Hyperlordotic Interbody Fusion Devices should never be reused under any circumstances. Reuse may result in, but is not limited to the following; infection or bending, loosening or breakage due to impairment of implant integrity.
  2. The ENDOSKELETON™ TAS or ENDOSKELETON™ TAS Hyperlordotic Interbody Fusion Device should never be implanted in patients with a systemic or local infection.
  3. The ENDOSKELETON™ TAS or ENDOSKELETON™ TAS Hyperlordotic system should not be used with components of any other interbody systems.
  4. The ENDOSKELETON™ or TAS ENDOSKELETON™ TAS Hyperlordotic device should not be implanted in patients with an allergy to titanium or titanium alloys.
  5. All patients should have at least 6 months of non-operative care prior to spinal fusion with the ENDOSKELETON™ TAS or ENDOSKELETON™ TAS Hyperlordotic device.
  6. The ENDOSKELETON™ TAS or ENDOSKELETON™ TAS Hyperlordotic Interbody Fusion Device should not be implanted in patients with a prior fusion at the level(s) to be treated.

PRECAUTIONS

Preoperative:

  1. Only patients that meet the criteria described in the indications should be selected.
  2. Based on fatigue testing results, when using the ENDOSKELETON™ TAS or ENDOSKELETON™ TAS Hyperlordotic Interbody Fusion Devices, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact on the performance of this system.
  3. Safety and effectiveness has not been established in patients with the following conditions: morbid obesity; symptomatic cardiac disease; pregnancy; signs of local inflammation; fever or leukocytosis; metal sensitivity/allergy to the implants materials; any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count; grossly distorted anatomy due to congenital abnormalities; osteopenia, and/or osteoporosis (osteoporosis is a relative contraindication since this condition may limit the obtainable correction, the amount of mechanical fixation, and /or the quality of the bone graft); long term systemic corticosteroid use; active drug abuse; any case requiring the mixing of metals from different components; any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality, or anatomical definition; any patient unwilling to cooperate with the postoperative instructions; any time implant utilization would interfere with anatomical structures or expected physiological performance. Patient conditions and/or predispositions such as these should be avoided. Other conditions may exist where safety and effectiveness have not been established.
  4. Care should be used in handling and storage of the implants and instruments. The implants should not be scratched or otherwise damaged. Implants and instruments should be protected during storage especially from corrosive environments.
    Devices should be routinely inspected; if they exhibit wear, damage, corrosion, or discoloration they should be returned to Titan Spine for further evaluation.
  5. The type of construct to be assembled for the case should be determined prior to beginning the surgery.
  6. Because mechanical parts are involved, the surgeon should be familiar with the various components before using the equipment and should personally assemble the implants to verify that all parts and necessary instruments are present before the surgery begins.
  7. Proper implant selection and patient compliance to postoperative precautions will greatly affect surgical outcomes. Patients who smoke have been shown to have an increased incidence of nonunion. Therefore, these patients should be advised of this fact and warned of the potential consequences.
  8. Postoperative care is important. The patient should be instructed in the limitations of his/her metallic implant(s) and should be cautioned regarding weight bearing and body stress on the appliance prior to secure bone healing.

Intraoperative:

  1. Any instruction manuals should be carefully followed.
  2. At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to nerves may occur resulting in loss of neurological functions.
  3. The implant surfaces should not be scratched or notched since such actions may reduce the functional strength of the construct.
  4. Autograft bone must be placed in the area to be fused and the graft must be in contact with viable bone.
  5. Internal and external threads on instruments can be damaged by cross-threading. Inspect internal and external threads for damage prior to assembly. If threads are damaged, set the product aside and do not use. When threading components together, keep to the thread axis. Screw in the component as far as it will go and make sure that the product is flush with the insertion instrument. On all threaded connections, finger tighten only

Postoperative:

  1. The physician’s postoperative directions and warnings to the patient and corresponding patient compliance are extremely important.
  2. Detailed instructions on the use and limitations of the implant(s) should be given to the patient. If partial weight bearing is recommended or required prior to firm bony union, the patient must be warned that bending, loosening or breakage of the implant(s) are complications which can occur as a result of excessive or early weight bearing or excessive muscular activity. The risk of bending, loosening or breakage of an internal fixation device during ostoperative rehabilitation may be increased if the patient is active or if the patient is debilitated, demented or otherwise unable to use crutches or other such weight supporting devices. The patient should be warned to avoid falls or sudden jolts in spinal position.
  3. To allow maximum chances for a successful surgical result, the patient should not be exposed to mechanical vibrations that may loosen the implant(s). The patient should be warned of this possibility and instructed to limit and restrict physical activities, especially lifting, twisting motions and any type of sport participation. The patient should be advised not to smoke or consume alcohol during the bone graft healing process.
  4. The patient should be advised of their inability to bend at the point of spinal fusion and taught to compensate for this permanent physical restriction on body motion.
  5. If a nonunion develops or if the implant(s) loosen, bend and /or break, the implant(s) should be revised and/or removed immediately before serious injury occurs. Failure to immobilize a delayed or nonunion of bone will result in excessive and repeated stresses on the implant(s).
    By the mechanism of fatigue these stresses can cause eventual bending, loosening or breakage of the implant(s). It is important that immobilization of the spinal surgical site be maintained until firm bony union is established and confirmed by roentgenographic examination. The patient must be adequately warned of these hazards and closely supervised to insure cooperation until bony union is confirmed.
  6. Any retrieved implants should be treated in such a manner that reuse in another surgical procedure is not possible. As with all orthopedic implants, none of the ENDOSKELETON™ TAS or ENDOSKELETON™ TAS Hyperlordotic Interbody Fusion implants should ever be reused under any circumstances. Reuse may result in, but is not limited to the following; infection or bending, loosening or breakage due to impairment of implant integrity.

ADVERSE EVENTS

Possible adverse effects include, but are not limited to, bending, loosening, or fracture of the implants or instruments; loss of fixation; sensitivity to a metallic foreign body, including possible tumor formation; skin or muscle sensitivity in patients with inadequate tissue coverage over the operative site, which may result in skin breakdown and/or wound complications; nonunion or delayed union; infection; nerve or vascular damage due to surgical trauma, including loss of neurological function, dural tears, radiculopathy, paralysis, and cerebral fluid leakage; gastrointestinal, urological and/or reproductive system compromise, including sterility, impotency, and/or loss of consortium; pain or discomfort; bone loss due to resorption or stress shielding, or bone fracture at, above, or below the level of surgery (fracture of the vertebra); hemorrhage of blood vessels and/or hematomas; malalignment of anatomical structures, including loss of proper spine curvature, correction, reduction, and/or height; bursitis; bone graft donor site pain; inability to resume activities of normal daily living; reoperation or death.