NuVasive has issued an urgent field safety notice for the recall of Magec System Model X rods. The notice, issued on 13 February, indicates that separation of an actuator end cap component has been observed in around 0.5% of implanted rods.
The Magec System is used to brace the spine during growth to minimise the progression of scoliosis. According to NuVasive, the rod may continue to lengthen or serve as an internal brace after the separation of the end cap component. However, the long-term ability of a rod with a separated actuator end cap to continue to lengthen/distract is currently unknown, NuVasive said in its safety notice.
The notice adds: “Post-implantation separation of an actuator end cap component has been observed in Magec System Model X rods. Post-market surveillance data have shown this actuator end cap separation to have occurred in approximately 0.5% of this device.
“This issue has only been observed in Model X rods, and therefore the prior version rods of the Magec System are not affected by this FSN [field safety notice].”
The cause of the issue is currently under investigation. NuVasive has asked healthcare providers to not to implant the Model X rods until further notice.