FDA Flags Certain Biocompatibility Concerns For NuVasive's Orthopedics' Precice Devices

The FDA informed healthcare providers of potential biocompatibility concerns with NuVasive Inc's NUVA specialized orthopedics' Precice devices.
Precice devices are implants for 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 agency has recommended stopping the implant of new stainless steel-based Precice devices.
The adverse events could be related to corrosion, wear, and previously unanticipated exposure of components undergoing biocompatibility testing.
The FDA noted that, at this time, it remains uncertain if the root cause is related to the stainless steel material or related to design features and materials common to all Precice devices.
As of now, the FDA is not aware of adverse events related to biocompatibility issues with titanium-based Precice devices, although it said NuVasive continues to investigate the root cause of the problems and has initiated a voluntary recall for titanium-based devices.
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