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Spinal implant: All MAGEC Systems – supply suspended to the UK (MDA/2020/011)

Spinal implant: All MAGEC Systems – supply suspended to the UK (MDA/2020/011) Manufactured by NuVasive Specialized Orthopedics – supply of all MAGEC rods suspended to the UK market during a review by MHRA. NuVasive has undertaken voluntary action to suspend the supply of all MAGEC rods to the UK to address concerns identified by MHRA over the continued use of the device. This action is described in the Field Safety Notice issued by the manufacturer dated 01 April 2020. MHRA issued a Medical Device Alert MDA/2020/010, dated 18 March 2020, which addressed the need for additional clinical follow-up in relation to the MAGEC Model X following the manufacturer’s Field Safety Notice dated 13 February 2020. The manufacturer has previously issued the following FSNs for problems such as locking pin breakage, O-ring seal failure, generation of metal wear debris, and failure of the rod to distract affecting other MAGEC generations.

Medical Device Alert