M6‑C Artificial Cervical Disc: safety alert and potential claims
Leigh Day is investigating legal claims on behalf of patients affected by the M6-C Artificial Cervical Disc following growing international reports of complications in patients and increasing scrutiny from regulators.
What is the M6-C Artificial Cervical Disc?
The M6‑C Artificial Cervical Disc, manufactured by Orthofix, is a spinal implant designed to treat cervical disc degeneration. It replaces a damaged disc in the neck, helping to preserve movement between the vertebrae and relieve pain, while avoiding the need for spinal fusion.
Early safety concerns and international alerts
Concerns about the disc are not new. In 2020, the Australian regulator issued a safety alert regarding the device, warning that there was “insufficient information regarding the potential consequences of periprosthetic osteolysis” (bone loss around the implant).
The regulator recommended that patients with the implant should be placed under long‑term clinical monitoring due to uncertainty about its long‑term safety.
Read the Australian safety notice regarding the M6-C implant hazard alert.
UK MHRA safety alert for the M6-C implant
In January 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a safety notice concerning the M6‑C Artificial Cervical Disc.
The alert followed increasing reports of serious complications in patients, particularly osteolysis (bone loss) and implant failure.
Following a review of the available evidence, the MHRA identified a number of significant risks associated with the implant, including:
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Progressive bone loss around the implant (osteolysis)
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Implant instability or failure
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The need for further or complex revision surgery
As a result, hospitals are now required to identify patients who have received an M6‑C implant, contact them directly, and ensure they are placed into long-term monitoring programmes.
View the MHRA safety notice regarding new monitoring requirements for the risk of osteolysis.
Discontinuation of the M6-C device
It is important to note that the product is no longer manufactured. In February 2025, the manufacturer, Orthofix, announced that it would discontinue the M6‑C artificial cervical disc as part of a strategic shift in focus.
Read the Orthofix Medical Inc. announcement regarding 2024 results and the discontinuation of the device.
What does the medical evidence show about M6-C complications?
A growing body of medical literature has raised concerns about the underlying mechanisms driving these complications.
A study published in the European Spine Journal found that microscopic wear particles released from the implant can trigger a biological inflammatory response, leading to:
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Activation of immune cells
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Release of inflammatory proteins
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Progressive destruction of bone surrounding the implant
This process can ultimately result in osteolysis, implant instability, and neurological complications, even where patients experience few or no early symptoms.
Read the European Spine Journal study on midterm osteolysis-induced aseptic failure of the M6-C cervical disc replacement.
Further large‑scale data analysis supports these concerns. A 2025 study using the MAUDE database (Manufacturer and User Facility Device Experience) in the United States found that:
- The M6-C device accounted for 138 reported osteolysis events
- It showed the highest reported rate of osteolysis (36.2%) among commonly used cervical disc replacements
The authors concluded that these findings give rise to “substantial concerns” regarding the association between the M6-C implant and osteolysis.
Read the International Journal of Spine Surgery analysis on rates of osteolysis for commercially available cervical disc devices in the USA.
Have you been affected by a faulty medical device?
If you have had an M6‑C cervical disc implanted, it is important to seek medical advice if you notice symptoms such as worsening neck pain, pain or tingling in the arms, weakness, or problems with balance.
Even if you feel well, you should take part in any monitoring programme arranged by your hospital, as complications may develop gradually and without early warning signs.
How Leigh Day can help with M6-C Cervical Disc claims
We are currently investigating potential medical device claims for people who have:
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developed osteolysis
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experienced implant failure
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required further surgery
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suffered ongoing symptoms after implantation
Get in touch
If you have received an M6‑C cervical disc and have concerns about your health, or have been contacted about monitoring, you may wish to seek legal advice and can contact our specialist product liability solicitor, Angela Bruno via email at abruno@leighday.co.uk.