Freedom® Cervical Disc Use In The Treatment of Cervical Degenerative Disc Disease

Exclusion Criteria

• •Subject with axial neck pain only who does not demonstrate concurrent arm pain or progressive neurological deterioration (specifically numbness or muscle weakness in the arm).
• •An active infection at the operative site or active systemic infection at the time of surgery.
• •Known or suspected allergy to titanium, polyurethane, cobalt, chromium, molybdenum or silicone.
• •Previous spinal fusion at the involved, or adjacent, cervical level(s).
• •Congenital or acquired structural defect at the operative levels (s) or their immediately adjacent level(s).
• •Significant osteoporosis in the cervical spine.
• •The investigator should assess if the subject has any of the following conditions at the index or adjacent level(s) which excludes the subject from study participation:
• •Cervical facet degeneration of the involved C3-C7 levels.
• •Previous trauma to, or fusion in, the C3-C7 levels.
• •Cervical instability at the index level(s) on neutral lateral or flexion/extension x-rays.
• •Radiographic findings of a fused or total collapsed disc.
• •Significant global cervical kyphosis (≥15º on Cobb angle measurement) or significant reversal of lordosis.
• •Female of childbearing potential, pregnant, breast feeding, or interested in becoming pregnant in the next two years