MAGnetic Expansion Control X (MAGEC X) system
The Medicines and Healthcare products Regulatory Agency (MHRA) is satisfied that the modified MAGEC X system (orthopaedic spinal rod for use in skeletally immature patients less than 10 years of age) can now be used in the UK.
The MHRA has reviewed the technical and biological safety information provided by NuVasive Specialized Orthopedics (NSO) and has lifted the suspension.
NSO has agreed to meet a set of conditions to monitor the long-term safety and performance of the device.
Note: All previous generations of the MAGEC system (MAGEC 1,1.5, 2B) remain suspended in the UK and should not be implanted.
Actions for healthcare professionals
The modified MAGEC X system can now be appropriately selected for use in surgery.
- Follow the actions set out in the manufacturers FSN.
- The modified MAGEC X system should only be implanted in accordance with the manufacturer instructions for use.
- There are specific reporting arrangements for healthcare professionals to follow in each region. Healthcare professionals should report incidents:
- In England and Wales to the Yellow Card scheme or via the Yellow Card app.
- In Scotland to Incident Reporting & Investigation Centre (IRIC) and their local incident recording system.
- In Northern Ireland to the Northern Ireland Adverse Incident Centre and their local incident recording system.
Actions for patients and carers
- If your child or dependent have been waiting for surgery during the period of the UK suspension of these devices, you should discuss the options available to them with their medical team. The use of a particular device will depend upon the clinical decision making for the patient.
- If your child or dependent has a device implanted and they experience any pain or other problems associated with the implant, please speak to your implanting surgeon/ hospital in the first instance.
- If your child or dependent is due to have the device implanted, you may be invited to participate in post-market clinical follow-up activities. MHRA strongly recommends patient involvement to ensure the safety and effectiveness of the device can continue to be stringently monitored.
- Report any suspected or actual adverse incidents to the MHRA using the Yellow Card scheme website.
Further details can be found here.