Risks of the PRESTIGE® LP Cervical Disc include, but are not limited to: early or late loosening of any or all components and development of new radiculopathy, myelopathy or pain.


BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, AND WARNINGS FOR THE PRESTIGE® LP CERVICAL DISC:


The PRESTIGE® LP Cervical Disc is indicated in skeletally mature patients for reconstruction of the disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to a single-level abnormality localized to the level of the disc space and at least one of the following conditions confirmed by imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The PRESTIGE® LP Cervical Disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of non-operative treatment or have had the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management prior to implantation of the PRESTIGE® LP Cervical Disc.

The PRESTIGE® LP Cervical Disc should not be implanted in patients with an active systemic infection or localized infection at the surgical site; osteoporosis defined as a DEXA bone mineral density T-score equal to or worse than -3.5 or a T-score equal to or worse than -2.5 with vertebral compression fracture, or osteopenia defined as a DEXA bone mineral density T-score <= -1.0; allergy or sensitivity to titanium, aluminum or vanadium; marked cervical instability on neutral resting lateral or flexion/extension radiographs; translation >3.5mm and/or >11° rotational difference from that of either adjacent level; severe spondylosis at the level to be treated, characterized by bridging osteophytes, loss of disc height >50%, an absence of motion (<2°) as this may lead to a limited range of motion and may encourage bone formation (e.g. heterotopic ossification, fusion); severe facet joint arthropathy; significant cervical anatomical deformity or clinically compromised vertebral bodies at the affected level due to current or past trauma (e.g., by radiographic appearance of fracture callus, malunion or nonunion) or disease (e.g., ankylosing spondylitis, rheumatoid arthritis); significant kyphotic deformity or significant reversal of lordosis; or symptoms attributed to more than one cervical level.

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