The supply of MAGEC rods manufactured by NuVasive Specialized Orthopedics has been suspended to the UK market as the Medicines and Healthcare products Regulatory Agency (MHRA) conducts a review.
The move follows reports of post-implantation fracture of the locking pin in MAGEC System Rods manufactured prior to 26 March 2015. Post-market surveillance data have shown this issue to occur in approximately 5 per cent of the total number of devices manufactured prior to 26 March 2015. These devices are no longer available for sale or implantation. Post-market surveillance data suggest the problem does not affect devices manufactured on or after 26 March 2015.
The MHRA recommends that MAGEC Systems should not be used in the UK until further notice. It advises that patients implanted with a MAGEC System should be identified and processes should be in place to follow up these patients.
Patients with the MAGEC Model X should receive an X-ray within three months of 18 March 2020.
Advise all patients about the possible complications and the alternative treatment options available.
Continue patient monitoring as per the manufacturer’s instructions, using X-ray imaging instead of ultrasound.
Due to the current COVID-19 health care crisis, follow-up and assessments should be risk assessed and completed as soon as possible.
In the exceptionally rare case where the device is deemed clinically essential, the MHRA will consider these on a case-by-case basis (email: AIC@mhra.gov.uk).
Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate, and directly to the manufacturers if local or national systems do not.
In all cases, the benefit of ionising radiation screening should be weighed against the risks from radiation exposure.
