Device safety informationMHRA
M6-C Artificial Cervical Disc, Spinal Kinetics LLC safety warning over a malfunction
The MHRA has conducted an assessment following reports of osteolysis and early device failure in the literature and is issuing new monitoring requirements for patients implanted with the M6-C artificial cervical disc.
What to do now
A malfunction affecting M6-C Artificial Cervical Disc, Spinal Kinetics LLC has been reported to the MHRA.
- If you use this device at home, do not stop treatment without speaking to the team who supplied it.
- Compare the details on the device or its box with the list here.
- Report problems with medical devices to the MHRA Yellow Card scheme.
Why it matters. A device that fails at the wrong moment can delay treatment or cause injury.
Replacements and support
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices.
If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2026/001). Quoted as issued.
Summary
The MHRA has conducted an assessment following reports of osteolysis and early device failure in the literature and is issuing new monitoring requirements for patients implanted with the M6-C artificial cervical disc.
The risk
Summary 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. Advice for Healthcare Professionals:
Advice for healthcare professionals
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.
Clinical follow-up recommendation:
trusts/ hospitals should review local records to identify patients implanted with the M6-C device and invite them for active monitoring of their implant
all identified patients should be contacted to inform them of the active monitoring programme and advised to contact their surgeon if they experience any new or unexpected symptoms
patients that have the M6-C device implanted should be actively monitored for signs and symptoms of osteolysis
all patients should receive an anterior-posterior and lateral X-ray of the cervical spine on an annual basis that is reviewed clinically irrespective of whether they have symptoms
follow the guidance from the British Association of Spine Surgeons
if a patient has symptoms and/or osteolysis is suspected from their X-ray, further scanning such as CT or MRI will be required to evaluate the implant further. Appropriate follow-up should be adjusted based on an individual patient basis
if a patient has osteolysis, surgeons should discuss the available options with them based on the clinical presentation of the patient. If revisional surgery is required, this should be carried out by a spinal surgeon with experience in revisional cervical spine surgery
if hospitals need to prioritise patients for recall, patients with multi-level implantations of the M6-C device should be prioritised as the indications for use has been updated to exclude multi-level implantations
if you experience any new or unexpected symptoms including increasing neck pain, arm pain radiating from the neck, pins and needles in the hands or arm, weakness in the hands or arms electric type sensations into the arms or trunk on neck movements or weakness or loss of balance in their legs, speak to your implanting surgeon or the hospital where your surgery was performed in the first instance
if you have had an M6-C device implanted, it is important you have had a recent X-ray in the last 12 months
Advice for patients
if you experience any new or unexpected symptoms including increasing neck pain, arm pain radiating from the neck, pins and needles in the hands or arm, weakness in the hands or arms electric type sensations into the arms or trunk on neck movements or weakness or loss of balance in their legs, speak to your implanting surgeon or the hospital where your surgery was performed in the first instance
if you have had an M6-C device implanted, it is important you have had a recent X-ray in the last 12 months
if you have had an M6-C device implanted, you should expect to be contacted by your surgeon or implanting hospital. There is no need to contact your surgeon or implanting hospital directly if you have no new or unexpected symptoms
Open the MHRA notice
Questions
Why has M6-C Artificial Cervical Disc, Spinal Kinetics LLC been recalled?
A malfunction affecting M6-C Artificial Cervical Disc, Spinal Kinetics LLC has been reported to the MHRA. A device that fails at the wrong moment can delay treatment or cause injury.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
If you use this device at home, do not stop treatment without speaking to the team who supplied it. Compare the details on the device or its box with the list here.
Who replaces the device?
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices. If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.