Device Safety Information – DSI/2026/001

The MHRA has conducted an assessment following reports of osteolysis and early device failure in the literature. The MHRA found that there was a delay in the manufacturer’s communication of the risks of osteolysis, change in indications for use and updates to the product information to users and patients in the UK. Patients implanted with the M6-C artificial cervical disc should be informed of the risks of osteolysis, receive annual routine monitoring and discuss the need for further investigation and continued follow-up.