April 2020: This guidance has been withdrawn while the MHRA conducts an investigation into the MAGEC system. The MHRA issued a Medical Device Alert MDA/2020/011 for all MAGEC systems. This is in response to the manufacturer’s latest Field Safety Notice and previous field safety notices for problems that may require early removal of devices and lead to inadequate treatment.
The MHRA is not recommending prophylactic removal of devices but the supply of all MAGEC systems is suspended in the UK while the MHRA investigation is ongoing. The MHRA has set out the following actions:
- Do not implant MAGEC rods in the UK until further notice.
- Identify all patients implanted with a MAGEC System and ensure systems are in place to follow up these patients.