Targeted communication: CE mark suspended for all MAGEC systems manufactured by NuVasive Specialized Orthopedics, Inc. (DSI/2021/007)

Recommendations for clinicians including not implanting these devices

From:
Medicines and Healthcare products Regulatory Agency
Published
10 May 2021
Message type:
Device safety information
Medical specialty:
Orthopaedics
Issued:
10 May 2021

Post-publication note: February 2024

Following an extensive assessment by the MHRA, we can advise that as of Friday 23 February 2024, the UK suspension has been lifted for use of the MAGnetic Expansion Control (MAGEC) System (modified MAGEC X system only). The MHRA is satisfied that NuVasive Specialized Orthopedics (NSO) has put in place sufficient measures to provide reassurance about the safety of these devices. The MHRA will continue to monitor the situation and will take action if necessary. Further communications to the healthcare system, patients and public will be issued shortly.

This was a targeted communication sent to specific professional associations. It was sent on Thursday 6 May 2021 and is being published here for information.

In March 2020, NuVasive Specialized Orthopedics, Inc. (NSO) voluntarily suspended the supply of MAGEC systems to the UK. This was on the request of the MHRA, pending the outcome of an MHRA investigation. This was communicated by the MHRA’s Medical Device Alert and a Field Safety Notice (FSN) issued by NSO on 01 April 2020.

The MHRA’s investigation has identified several deficiencies with the technical documentation relating to MAGEC systems and NSO’s quality management system. The MHRA sent its initial findings to NSO and their EU Notified Body in September 2020. Following this report, the Notified Body undertook its own review, which resulted in the CE certificate being suspended on 25 March 2021. Additional details on MHRA’s investigation will be communicated in due course.

The MHRA, in consultation with its independent Spinal Expert Advisory Group, has continued to monitor the safety and performance of the MAGEC system. We recognise that there are additional uncertainties stemming from the suspension of the CE certificate and, following feedback from the clinical community, we have updated our recommendations for clinicians.

MHRA’s recommendations

  • Do not implant MAGEC rods in the UK until further notice.

  • Identify all patients who currently have a MAGEC System implanted and inform them, and their families, of the contents of this letter.

  • Consult the IFU throughout the patient’s treatment with the MAGEC system.

  • Ensure systems are in place to follow up patients who have the device implanted. Continue to undertake follow-up of all patients according to normal clinical practice. Users should follow the appropriate postoperative procedure to assess the MAGEC System by X-ray imaging* whenever the device is adjusted or at a minimum of once every six months. The most recent images should be compared to immediate post-operative images to help identify signs of device failure, including component fracture or migration.

  • Where removal will not cause additional harm:
    • If a component of the device is found to be broken, remove the device as soon as possible (Priority 3 under the current clinical guide to surgical prioritisation).
    • Check to make sure the rod is still distracting and if it is not, remove it as soon as possible (Priority 3 under the current clinical guide to surgical prioritisation).
    • Remove the device at the end of the distraction treatment and do not use it as a brace unless there is a specific medical reason to do so.

  • Where the rod is intact and still functioning, continue to monitor.

  • Report any suspected or actual adverse incidents involving these devices through your healthcare institution’s local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.

  • Ensure clinicians are aware of the content of this letter and the previous safety communications issued about the system (ordered by date):

*In all cases, the benefit of ionising radiation screening should be weighed against the risks from radiation exposure on an individual patient basis, in line with the requirements of The Ionising Radiation (Medical Exposure) Regulations 2017.

Exceptional use applications

At present, the MHRA has not had sight of the Notified Body’s assessment that led to the suspension of the CE certificate, or the manufacturer’s proposed corrective actions. Without this information, the uncertainties about the device cannot be fully assessed when considering applications for exceptional use. Therefore, the MHRA will not accept any further applications for exceptional use.

If CE certification is reinstated and the MHRA has been able to review the Notified Body’s assessment, including the manufacturer’s corrective action plan, we will reconsider this position.

Background information on CE certificate suspension

On 25 March 2021 NSO informed the MHRA that their CE certification for the MAGEC system had been suspended by their EU Notified Body.

By way of background, Notified Bodies are independent organisations designated by an EU Member State to undertake pre-market assessments to ensure that manufacturers, and their medical devices, meet the requirements of the legislation. Only then does the Notified Body issue a CE certificate, which in turn allows a manufacturer to place a CE mark on their device.

At present the UK continues to recognise CE marked medical devices and will do so until 30 June 2023. Therefore, providing a medical device has been CE marked, this medical device can continue to be used in the UK.

In cases where non-conformities with the regulations or safety issues with the device become evident, the Notified Body may suspend or withdraw a CE certificate. Suspension or withdrawal of a CE certificate prevents the device being placed on the market in the EU and UK.

The MHRA continues to work closely with the independent Spinal Expert Advisory Group and representatives of the specialty to provide supplementary information to support patients and clinicians, which we anticipate will be published soon.

Devices Safety and Surveillance Group

Medicines and Healthcare products Regulatory Agency

aic@mhra.gov.uk quoting ref TL/2021/06

gov.uk/mhra

Published 10 May 2021