Instructions for use of the Magec rods — designed for bracing the spine as it grows to minimize the progression of scoliosis — indicate that the implants can loosen, fracture, corrode, migrate or cause pain, according to the Dec. 7 advisory notice.
NuVasive said the issues can manifest in vivo as locking pin breakage, O-ring seal failure, generation of metal wear debris and failure of the rod to distract. Use of the Magec rod may also lead to localized tissue discoloration.
A review of the rods is being conducted by DQS Medizinprodukte GmbH, the notified body that granted Magec CE marking.
Patients implanted with a Magec rod may need to undergo a removal or revision surgery for a variety of reasons.
NuVasive does not recommend a prophylactic removal of a functioning rod. The company said decisions like this should be made by the consulting surgeon in conjunction with the patient.
Read the full advisory notice here.
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