FDA Issues Alert on NuVasive’s Magec Implants
The FDA has issued an alert about potential mechanical failures and concerns about tissue incompatibility associated with components of NuVasive’s Specialized Orthopedics’ Magec devices.
The affected devices include the Magec and Magec 2 Spinal Bracing and Distraction Systems, the Magec System, the Magec System Model X device and rod, and Magec System Rods.
The FDA cited reports of “endcap separation, O-ring seal failure and potential exposure of internal components of the device to living tissue that may lead to adverse local tissue reactions.”
But the FDA said it still believes the benefits of a Magec device outweigh the risks if used in accordance with the indications it has cleared and says it “does not recommend the removal of functioning Magec rods” until two years after implantation.