The FDA is warning healthcare providers about biocompatibility concerns with NuVasive’s Precice devices.
Precice devices are implants made of adjustable rods with an internal magnetic mechanism. The magnetic mechanism is adjusted to lengthen limbs, shorten limbs, or transport bone segments.
Unfortunately, patients with the stainless-steel Precice implants have reported pain, changes in the surrounding bone, and soft tissues.
On April 5, NuVasive announced that it was halting global shipments of all Precice devices while they undergo biocompatibility testing.
At this time, the FDA said it is unclear if the problem is related to the stainless-steel material or design features with all Precice devices.
The FDA believes the problems “may be related to corrosion, wear, and previously unanticipated exposure of components that are undergoing biocompatibility testing,” according to the warning letter.
NuVasive’s stainless steel Precice devices include the Precice Bone Transport, the Precice Plate, and the Precice Stryde.
The titanium-based Precice devices include the Precice Freedom, the Precice Intra-medullary Limb Lengthening device, the Precice Short, and the Precice Unyte.