PEEK PREVAIL® Cervical Interbody
0381384E Rev. B
Device
2016-03-18
IMPORTANT INFORMATION ON THE PEEK PREVAIL® CERVICAL INTERBODY
DEVICE
PURPOSE
The PEEK PREVAIL® Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally
mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. This system is indicated for
single-level use only in the C2-T1 anterior spine.
DESCRIPTION
The PEEK PREVAIL® Cervical Interbody Device is an intervertebral body fusion device with internal screw fixation. The screws
protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant.
The implant is “I-Beam” shaped with a 2 screw midline configuration. This device is intended to be radiolucent and the interior
space of the product is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or
corticocancellous bone graft.
The PEEK PREVAIL
radiopaque markers and a Nitinol screw locking mechanism. The screws used with this device (ZEPHIR
Screws) are manufactured from titanium alloy.
Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.
Based on fatigue testing results, when using the PEEK PREVAIL
consider the levels of implantation, patient weight, patient activity level, other patient conditions,etc., which may impact the
performance of this system. Patients with previous spinal surgery at the level(s) to be treated may have different clinical
outcomes compared to those without a previous surgery.
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Cervical Interbody device implant is manufactured from PEEK Optima LT1® and contains tantalum
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Cervical Interbody device, the physician/surgeon should
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Anterior Cervical
INDICATIONS
The PEEK PREVAIL® Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally
mature patients with cervical disc disease at one level 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. The PEEK PREVAIL
Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK
PREVAIL
of cancellous and/or corticocancellous bone graft and implanted via an open, anterior approach. This cervical device is to be
used in patients who have had six weeks of non-operative treatment.
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Cervical Interbody Device implants are to be used with autogenous bone graft and/or allogenic bone graft comprised
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CONTRAINDICATIONS
The PEEK PREVAIL® Cervical Interbody device is not intended for posterior surgical implantation. Contraindications include,
but are not limited to:
▪ Any case needing to mix metals from different components.
▪ Any case not described in the indications.
▪ 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.
▪ Mental illness.
▪ Morbid obesity.
▪ Pregnancy.
▪ Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis. Osteoporosis is a relative contraindication since this
condition may limit the degree of obtainable correction and/or the amount of mechanical fixation.
▪ Signs of local inflammation.
▪ Suspected or documented metal allergy or intolerance.
▪ These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth.
Contraindications of this device are consistent with those of other spinal systems.
POTENTIAL ADVERSE EVENTS
All of the possible adverse events or complications associated with spinal fusion surgery without instrumentation are possible.
With instrumentation, a listing 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.
▪ Cessation of any potential growth of the operated portion of the spine.
▪ Loss of spinal mobility or function and inability to perform the activities of daily living.
▪ Change in mental status.
▪ Death.
▪ Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.).
▪ Disassembly, bending, and/or breakage of any or all of the components.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, and/or meningitis.
▪ Early or late loosening of the components and 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.
▪ 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 neurologial function, including paralysis (complete or incomplete), dysesthesia, hyperesthesia, anesthesia,
paraesthesia, appearance of 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 mal-union.
▪ 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
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. The PEEK PREVAIL
ZEPHIR
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.
Never reuse an internal fixation device under any circumstances. Even when a removed device appears undamaged, it may
have small defects or internal stress patterns that may lead to early breakage. Damage of the thread will reduce the stability of
the instrumentation.
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.
An implanted device should never be re-used unless otherwise specified. Implants which have come in contact with the patient
are designed for single patient use only. Do not reuse, reprocess, or re-sterilize used implants. Reuse, reprocessing, or resterilization may compromise the structural integrity of these implants and create a risk of contamination of the implants which
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Anterior Cervical Screws to augment stability. Use of this product without autogenous bone graft and/or allogenic
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Cervical Interbody Device must be used with the
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