Device safety informationMHRA
MAGEC X System, NuVasive Specialized Orthopedics (NSO) safety warning over a safety concern
The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the modified MAGEC X system can now be used in the UK.
What to do now
The MHRA has published safety information about MAGEC X System, NuVasive Specialized Orthopedics (NSO).
- 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. Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
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/2024/002). Quoted as issued.
Summary
The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the modified MAGEC X system can now be used in the UK.
The risk
Devices Details Device Name: MAGnetic Expansion Control X (MAGEC X) system (orthopaedic spinal rod for use in skeletally immature patients less than 10 years of age) Affected lot numbers/serial numbers: All MAGEC X systems
Advice for healthcare professionals
The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the modified MAGEC X system can now be used in the UK.
NSO has agreed to meet a set of conditions to monitor the long-term safety and performance of the device.
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
Open the MHRA notice
Questions
Why has MAGEC X System, NuVasive Specialized Orthopedics (NSO) been recalled?
The MHRA has published safety information about MAGEC X System, NuVasive Specialized Orthopedics (NSO). Device safety information tells healthcare staff and, where relevant, patients about risks and the actions needed.
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.