NuVasive (NSDQ:NUVA) issued an urgent field safety notice to warn users of an issue with the separation of a certain component in its Magec system model X rods.
According to the safety notice, post-implant separation of an actuator end cap component was observed in the rods. Data from post-market surveillance revealed that the end cap separation occurred in approximately 0.5% of the devices. The issue only occurred in model X rods, so previous versions of the Magec system are not affected.
The Magec system is designed to brace the spine during growth to minimize the progression of scoliosis. The model X rod may lengthen, distract and/or serve as an internal brace after the end cap component is separated, but the long-term ability of such a rod is currently unknown.
If the end cap is separated, internal components could wear out more quickly titanium alloy debris could be releases, causing localized tissue discoloration. Affected model X rods were first manufactured on July 27, 2017 and the root cause of the issue is being investigated, the company said.
Users are urged not to implant model X rods until further notice and assess implanted rods by X-ray imaging whenever the device is adjusted or at a minimum of once every six months. If end cap separation is observed, a decision to remove the device should be made by the physician in consultation with the patient and/or family.
NuVasive said it is not recommending prophylactic revision based on the separation of an end cap, but if that is detected, removal of the device may be indicated.