M6-C Artificial Cervical Disc, Spinal Kinetics LLC: New monitoring requirements for the risk of osteolysis

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.

Read the full update from MHRA

About MHRA alerts and recalls

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s regulator for medicines, vaccines and medical devices. One of its key responsibilities is to monitor the safety and effectiveness of products in use across the NHS and wider healthcare system. When new safety concerns are identified, or when issues arise with the manufacture or distribution of a medicine or device, the MHRA issues alerts and recalls to protect patients and support healthcare professionals.

These alerts can take several forms. Some provide updated guidance on prescribing or monitoring requirements for medicines and vaccines. Others may highlight newly recognised side effects, or remind clinicians of important risk-mitigation steps. In the case of medical devices, alerts may cover field safety notices, product recalls, or urgent device modifications. All of these communications are designed to ensure that products are used safely and that any risks are managed appropriately.

Patient.info republishes MHRA alerts and recalls so that this information is available quickly and accessibly to both healthcare professionals and the public. The summary above is taken directly from the MHRA’s official publication. To read the full advice, including detailed recommendations for prescribers, manufacturers and patients, please follow the “Read more” link to the MHRA website.

If you are a healthcare professional, you should consult the full notice to confirm the latest prescribing information, monitoring requirements and any actions you need to take in your practice. If you are a patient or carer, do not stop treatment or make changes to your medication or device without first seeking professional advice. If you have any concerns about your medicine or device, speak to your GP, pharmacist or specialist nurse.

Contains public sector information licensed under the Open Government Licence v3.0.