The Magec system is a metallic spinal implant designed for bracing the spine during growth to minimize the progression of scoliosis. Instructions for use of the device indicate that the implants can loosen, fracture, corrode, migrate or cause pain, according to the safety notice.
In March, NuVasive issued an urgent field safety notice to warn users of a specific issue with the separation of a certain component in its Magec system model X rods. The recent notice, dated Dec. 7, 2020, was a supplement to an initial notice released in February 2020.
According to NuVasive, the issues with the implant can manifest in vivo as locking pin breakage, o-ring seal failure, generation of metal wear debris and failure or the rod to distract. Localized tissue discoloration also may result from use of the Magec rod.
Magec maintains its CE Mark approval, but the notified body DQS Medizinprodukte GmbH is beginning a review of the system, while the company said it will work with DQS to that end.
Affected patients may need to undergo a removal/revision surgery for a number of reasons, while those considering the implantation of a Magec rod or rods should consider the ongoing review, according to the company. NuVasive does not recommend a prophylactic removal of a functioning rod.