Indications, Safety, and Warnings
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 who is thoroughly knowledgeable in the implant’s material and surgical aspects and who has been instructed as to its mechanical and material applications and limitations. This device is manufactured from medical grade polyetheretherketone (PEEK), tantalum markers, and a commercially pure titanium (CP Ti) coating. It is provided sterile.
Description
The Anatomic PEEK™ PTC cervical fusion system consists of cages of various widths and heights which can be inserted between one disc level or two contiguous levels to give support and correction during cervical 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 graft. The Anatomic PEEK™ PTC devices must be used with supplemental fixation.
No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.
Medical grade tantalum, medical grade CP Ti, and medical grade PEEK may be used together. Never use titanium or titanium alloy implants with stainless steel in the same construct.
Indications
The Anatomic PEEK™ PTC cervical fusion system is indicated for cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one disc level or two contiguous levels from the C2-C3 disc to the C7-T1 disc.
Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The
Anatomic PEEK™ PTC device is to be used with supplemental fixation. The Anatomic PEEK™ PTC cervical fusion system is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open anterior approach.
Contraindications
The Anatomic PEEK™ PTC device is not intended for posterior surgical implantation. Contraindications also include, but are not limited to:
Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery such as the presence of tumors or congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count
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 postoperative instructions
Fever or leukocytosis
Infection local to the operative site and/or signs of local inflammation
Mental illness
Morbid obesity
Pregnancy
Any case not requiring fusion
Suspected or documented allergy or intolerance to the component materials
This device must not be used for pediatric cases
Patients with a known hereditary or required bone friability or calcification problem should not be considered for this type of surgery
Prior fusion at the level to be treated
Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance
Any case that requires the mixing of metals from two different components or systems
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
All of the possible adverse events or complications associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a list of possible adverse events or complications includes, but is not limited to:
Bone loss or decrease in bone density possibly caused by stress shielding
Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits, arachnoiditis, and/or muscle loss
Loss of spinal mobility or function
Inability to perform the activities of daily living
Change in mental status
Death
Development of respiratory problems (e.g., pulmonary embolism, atelectasis, bronchitis, pneumonia)
Disassembly, bending, and/or breakage of any or all the components
Dural tears, pseudomeningocele, fistula, persistent CSF leakage, and/or meningitis
Early or late loosening of the components
Implant migration
Foreign body (allergic) reaction to the implants, debris, corrosion products, including metallosis, staining, tumor formation, and/or autoimmune disease
Fracture, microfracture, resorption, damage, penetration, and/or retropulsion of any spinal bone, of the autograft, or at the bone graft harvest site at, above, and/or below the level of surgery
Ileus, gastritis, bowel obstruction or other types of gastrointestinal complications
Graft donor site complications including pain, fracture, infection, or wound healing problems
Hemorrhage, hematoma, occlusion, seroma, edema, embolism, stroke, excessive bleeding, phlebitis, damage to blood vessels, or cardiovascular system compromise.
Wound necrosis or wound dehiscence
Herniated nucleus pulposus, disc disruption, or degeneration at, above, or below the level of surgery
Infection
Loss of neurological function, including paralysis (complete or incomplete), dysesthesia, hyperesthesia, anesthesia, paresthesia, appearance or radiculopathy, and/or the development or continuation of pain, numbness, neuroma, tingling sensation, sensory loss, and/or spasms
Non-union (or pseudarthrosis), delayed union, and/or malunion
Postoperative change in spinal curvature, loss of correction, height, and/or reduction
Scar formation possibly causing neurological compromise around nerves and/or pain
Subsidence of the device into vertebral body(ies)
Tissue or nerve damage, irritation, and/or pain caused by improper positioning and placement of implants or instruments
Note: Additional surgery may be necessary to correct some of these anticipated adverse events.
Warnings
This system was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.
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 in cervical interbody fusion procedures without autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft may not be successful.
No spinal implant can withstand body loads without the support of bone. In this event, bending, loosening, disassembly, and/or breakage of the device(s) will eventually occur.
Preoperative and operating procedures including knowledge of surgical techniques, proper selection and placement of the implant, and good reduction are important considerations in the success of surgery.
Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those without a previous surgery.
This system should not be used in any case not described in the indications.
Further, the proper selection and compliance of the patient will greatly affect the results. Patients who smoke have been shown to have an increased incidence of non-unions. These patients should be advised of this fact and warned of this consequence. Obese, malnourished, and/or alcohol abuse patients are also poor candidates for spine fusion.
Precautions
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.
Based on fatigue testing results, when using the Anatomic PEEK™ PTC cervical fusion system, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc. which may impact the performance of this system.
For United States audiences only.
Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.
Atlantis Vision™ Elite anterior cervical plate
Infinity™ OCT system
Prestige LP™ cervical disc
UNiD™ adaptive spine intelligence