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.
