IMPORTANT INFORMATION ON THE ARTIC-L™ 3D TI SPINAL SYSTEM WITHTIONIC™ TECHNOLOGY
PURPOSE
This device is a fusion device intended for stabilization 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 instructed as to its mechanical and material applications and limitations.
DESCRIPTION
The ARTiC-L™ 3D Ti Spinal System with TiONIC™ technology consists of additive manufactured titanium cages of various widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The articulating device assembly allows for placement of implant while remaining attached to inserter. The open geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate. The device is not intended to be used as a stand-alone implant.
Stainless steel and titanium implants are not compatible. They must not be used together in a construct. As with all orthopedic implants, in no case may the implants be re-used.
No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.
INDICATIONS
The ARTiC-L™ 3D Ti Spinal System with TiONIC™ technology is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the ARTiC-L™ 3D Ti Spinal System with TiONIC™ technology can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.
When used as an interbody fusion device, these implants are intended for use with supplemental internal fixation systems.
CONTRAINDICATIONS
This device is not intended for cervical spine use. Contraindications include:
- 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 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 or quality.
- Any patient in which implant use 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 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:
- Implant migration.
- Breakage of the device(s).
- Foreign body reaction to the implants including possible tumor formation, auto immune disease, and/or scarring.
- Pressure on the surrounding tissues or organs.
- Loss of proper spinal curvature, correction, height, and/or 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/or development of pain.
- 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/or hematomas.
- Discitis, arachnoiditis, and/or other types of inflammation.
- Deep venous thrombosis, thrombophlebitis, and/or 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/or pain.
- Fracture, microfracture, resorption, damage, or penetration and/or retropulsion of any spinal bone (including the sacrum, pedicles, and/or vertebral body) and/or bone graft or bone graft harvest site at, above, and/or below the level of surgery.
- 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 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 bone graft 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 implants are important considerations in the successful use of the system by the surgeon. Further, proper selection and compliance of the patient will greatly affect the results. Patients who smoke were shown to have a reduced incidence of bone fusion. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, and/or alcohol/drug abuse patients and those with poor muscle and bone quality and/or 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.
A device that has been implanted should never be re-used or re-processed under any circumstances. Sterile packaged devices are never to be re-sterilized. Re-use or reprocessing may compromise the structural integrity of the implants and create a risk of contamination of the implants.
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.
