The FDA today informed healthcare providers of potential biocompatibility concerns with Precice devices from NuVasive (NSDQ:NUVA).
Precice devices are implants for those 18 years of age and older and are used to lengthen the limb, shorten or compress the limb or transport segments of long bones. They include adjustable rods that are placed inside a patient and are driven by an internal magnetic mechanism.
According to an FDA notice, there have been reports describing pain and changes in surrounding bone and soft tissue in patients with the stainless steel-based Precice devices. The adverse events could be related to corrosion, wear and previously unanticipated exposure of components that are undergoing biocompatibility testing.