Without a lot number, the device history records review could not be completed. Additional information and the return of the device has been requested. This was a two-level implantation. In the us, the m6-c artificial cervical disc is indicated for use following a single level discectomy in skeletally mature patients with intractable degenerative cervical radiculopathy with or without spinal cord compression at one level from c3 - c7. The ifu states that the safety and effectiveness of the m6-c artificial cervical disc has not been established in patients with more than one cervical level requiring surgery.
Patient Sequence No: 1, Text Type: N, H10
It was reported that a patient with 2 m6-c artificial cervical discs was revised. The second device has now been removed.
Patient Sequence No: 1, Text Type: D, B5