Modified MAGEC X system for early onset scoliosis treatment can now be used in the UK
The UK suspension of the MAGEC system (modified MAGEC X system only) has been lifted as of 23 February 2024
Following an extensive assessment by the Medicines and Healthcare products Regulatory Agency (MHRA), as of 23 February 2024, the UK suspension of the MAGnetic Expansion Control (MAGEC) System (modified MAGEC X system only) has been lifted. The MHRA is satisfied that the manufacturer, NuVasive Specialized Orthopedics (NSO), has put in place sufficient measures to provide reassurance about the safety of this device.
The modified MAGEC X system can now be appropriately selected for use in surgery for early onset scoliosis treatment in accordance with the manufacturer’s instructions for use. All previous generations of the MAGEC system (MAGEC 1,1.5, 2B) remain suspended in the UK and should not be implanted. Parents and carers of children who have been waiting for surgery during the period of the UK suspension of these devices, should discuss the options available to them with their medical team.
MAGnetic Expansion Control X (MAGEC X) system is an orthopaedic spinal rod for use in skeletally immature patients less than 10 years of age. It helps correct spinal deformities as the child grows, minimising the need for repeated invasive surgeries to correct the spinal curve.
In March 2020, the manufacturer voluntarily suspended the supply of MAGEC systems to the UK. This was at the request of the MHRA, while the agency investigated emerging evidence relating to a series of ongoing technical failures with the device and evidence that the MAGEC system could not endure the 6-year implantation time under conditions of normal use. All MAGEC System devices were affected by the suspension, and this was communicated to the public on 1 April 2020.
The MHRA investigation identified some gaps in the long-term biological safety of the device. These findings were sent to the manufacturer’s Notified Body, who conducted its own review and suspended the CE certificate in March 2021.
After the CE certificate was reinstated in November 2021 with a revised shorter implantation time of two years, the MHRA completed an extensive assessment of the technical and biological safety information provided by the manufacturer and sought independent expert advice from the Spinal Expert Advisory Group (SEAG) to ensure that the original safety concerns had been addressed. The SEAG concluded that the UK suspension could be lifted if the manufacturer meets a number of conditions.
The manufacturer has agreed to a set of conditions regarding the long-term safety and performance of the MAGEC rods. These include post-market clinical follow-up studies to assess safety and performance including proactive monitoring of the risk of metal wear exposure in implanted patients, clear instructions for use, and that a specific generation of the MAGEC device (modified MAGEC X) are used. This modified generation has design updates aimed at mitigating some of the early technical failures previously observed.
The decision to use a specific device will depend on the clinical assessment of the patient’s needs. Healthcare professionals, carers, and patients are asked to follow the guidance provided in the MHRA’s Devices Safety Information. Healthcare professionals should strictly follow the actions outlined in the manufacturer’s Field Safety Notice.
The MHRA will continue to monitor the safety and performance of the MAGEC system. If anyone with this device implanted experiences any pain or other problems associated with the implant, they should contact their implanting surgeon or hospital. Any suspected or actual adverse incidents can be reported to the MHRA using the Yellow Card scheme website.
Notes to editors
- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- The MHRA’s role is to protect patients from harm by ensuring manufacturers do everything they can to mitigate residual risks that can be caused by medical devices.
- A Notified Body is the organisation that conducts a conformity assessment of medical devices against the technical requirements of the Medical Device Regulations before awarding a CE mark allowing the devices to be placed onto the market. In the UK we have approved bodies to issue UKCA certificates.
- On 25 March 2021, the MAGEC CE certificate was suspended by their Notified Body. In November 2021, the CE certification was reinstated.
- A letter detailing the conditions to lift the suspension was sent to NuVasive Specialized Orthopaedics (NSO) by the MHRA in October 2022. The conditions were agreed and accepted by NSO on 23 February 2024.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.