IMPORTANT INFORMATION ON THE CAPSTONE PTC™ SPINAL SYSTEM
PURPOSE
This device is a fusion device intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The product should be implanted only by a physician thoroughly knowledgeable in the implant's material and surgical aspects and who has been instructed as to its mechanical and material applications and limitations.
DESCRIPTION
The CAPSTONE PTC™ Spinal System consists of commercially pure titanium (CP Ti) coated PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
No warranties express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.
INDICATIONS
The CAPSTONE PTC™ Spinal System is indicated for interbody fusion in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Additionally, the CAPSTONE PTC™ Spinal System is indicated to assist in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis.
These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.
These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the Food and Drug Administration (FDA) for use in the lumbar spine.
CONTRAINDICATIONS
This device is not intended for cervical spine use. Contraindications include, but are not limited to:
- Infection local to the operative site.
- Signs of local inflammation.
- Fever or leukocytosis.
- Morbid obesity.
- Pregnancy.
- Mental illness.
- Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, fracture local to the operating site, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count.
- Suspected or documented allergy or intolerance to composite materials.
- Any case not needing a fusion.
- Any case not described in the indications.
- Any patient unwilling to cooperate with postoperative instructions.
- Patients with a known hereditary or acquired bone friability or calcification problem should not be considered for this type of surgery.
- These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth.
- Spondylolisthesis unable to be reduced to Grade 1.
- Any case where the implant components selected for use would be too large or too small to achieve a successful result.
- Any case that requires the mixing of metals from two different components or systems.
- Any patient having inadequate tissue coverage over the operative site or inadequate bone stock, bone quality, or anatomic definition.
- Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.
- Prior fusion at the level to be treated.
Nota bene: although not absolute contraindications, conditions to be considered as potential factors for not using this device include:
- Severe bone resorption.
- Osteomalacia.
- Severe osteoporosis.
POTENTIAL ADVERSE EVENTS
Adverse effects may occur when the device is used either with or without associated instrumentation. The potential risk of adverse effects as a result of movement and non-stabilization may increase in cases where associated complementary support is not employed. Potential adverse events include, but are not limited to:
- Implant migration.
- Breakage of the device(s).
- Foreign body reaction to the implants including possible tumor formation, auto immune disease, and scarring.
- Pressure on the surrounding tissues or organs.
- Loss of proper spinal curvature, correction, height, and reduction.
- Infection.
- Bone fracture or stress shielding at, above, or below the level of surgery.
- Non-union (or pseudoarthrosis).
- Loss of neurological function, appearance of radiculopathy, dural tears, and development of pain, numbness, neroma, tingling sensation, sensory loss, and/or spasms.
- Discitis, arachnoiditis, and/or other types of inflammation.
- Fracture, microfracture, resorption, damage, or penetration of any spinal bone including the sacrum, pedicles, and vertebral body, and bone graft or bone graft harvest site at, above, or below the level of surgery.
- Retropulsed graft.
- Neurovascular compromise including paralysis, temporary or permanent retrograde ejaculation in males, or other types of serious injury.
- Cerebral spinal fluid leakage.
- Hemorrhage of blood vessels and hematomas.
- Discitis, arachnoiditis, and or other types of inflammation.
- Deep venous thrombosis, thrombophlebitis, and pulmonary embolus.
- Bone graft donor site complication.
- Inability to resume activities of normal daily living.
- Early or late loosening or movement of the device(s).
- Urinary retention or loss of bladder control or other types of urological system compromise.
- Scar formation possibly causing neurological compromise or compression around nerves and pain.
- Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedicles, and vertebral body) and bone graft or bone graft harvest site at, above, or below the level of surgery.
- Retropulsed graft.
- Herniated nucleus pulposus, disc disruption, or degeneration at, above, or below the level of surgery.
- Loss of or increase in spinal mobility or function.
- Reproductive system compromise including sterility, loss of consortium, and sexual dysfunction.
- Development of respiratory problems (e.g., pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.).
- Change in mental status.
- Cessation of any potential growth of the operated portion of the spine.
- Death.
WARNINGS AND PRECAUTIONS
A device that has been implanted should never be reused, reprocessed, or resterilized under any circumstances. Sterile packaged devices should also never be resterilized. Reuse, reprocessing, or resterilization may compromise the structural integrity of these implants and create a risk of contamination of the implants which could result in patient injury, illness, or death.
When used in deformity procedures, undersizing the implant may limit endplate engagement and potentially lead to implant migration and/or expulsion.
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other patient conditions may compromise the results. Use of this product without autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone or in cases that do not develop a union will not be successful.
Preoperative and operating procedures including knowledge of surgical techniques, good reduction, and correct selection and placement of the implants are important considerations in the successful utilization of the system by the surgeon. Further, the proper selection and the compliance of the patient will greatly affect the results. Patients who smoke have been shown to have a reduced incidence of bone fusion. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, or alcohol/drug abuse patients, and those with poor muscle and bone quality and nerve paralysis are also poor candidates for spinal fusion.
Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those without a previous spinal surgery.
Physician note: although the physician is the learned intermediary between the company and the patient, the important medical information given in this document should be conveyed to the patient.
For US audiences only
Caution: federal law (USA) restricts these devices to sale by or on the order of a physician.
