FDA Warns of Biocompatibility Risks With NuVasive Specialized Orthopedics’ Precice devices

Healthcare professionals should stop using certain NuVasive stainless steel adjustable rods during orthopedic procedures, according to federal health regulators, who indicate a series of biocompatibility reports have been received involving patients suffering adverse health consequences.

The FDA issued a NuVasive Specialized Orthopedics’ Precice device warning on July 8, advising healthcare professionals to closely monitor patients who have been implanted with stainless steel and titanium-based Precice devices, to watch for bone and soft tissue changes surrounding the implant area.

The Precice devices are implantable and adjustable rods that are driven by an internal magnetic mechanism to lengthen limbs, shorten or compress the limb, or transport segments of long bones in adults. Devices covered by the warning include the NuVasive Precice Bone Transport, Precice Plate and Precice Stryde Stainless Steel (Biodur 108)-Based Precice devices as well as Precice Freedom, Precice Intra-medullary Limb Lengthening (IMLL) Device, Precice Short and Precice Unyte Titanium-Based Precice devices.

According to the warning, the stainless steel series of Precice devices have been associated with adverse events related to biocompatibility issues, which may have been caused by corrosion, wear, and unanticipated exposure of components still undergoing biocompatibility testing.

The FDA is aware of multiple patients experiencing problems with NuVasive Precice rods, including pain and changes in the surrounding bone and soft tissue after being implanted with a stainless steel model of the devices. Patients with the implanted devices should be checked for bone and soft tissue changes during routine radiographic monitoring, according to the warning. Officials indicate patients reporting increased pain or other unexpected symptoms should undergo additional radiographs and physical examination, with special attention to the area surrounding the telescoping junction of the implant.

The FDA announced that while the root cause of these reports is currently unknown, the agency will continue to work closely with NuVasive to perform additional biocompatibility testing to determine if the adverse events are due to the stainless-steel material or related to design features and materials common to all Precice devices.

While no adverse events have been reported in relation to the titanium Precice devices, healthcare providers are being instructed to perform routine follow ups with titanium Precice recipients for similar biocompatibility changes.

At this time, FDA officials are instructing all healthcare professionals to immediately stop implanting any new stainless steel Precice devices as NuVasive continues to investigate the root cause of issues.

On April 5, 2021, NuVasive issued a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global shipping hold on all Precice devices. The statement instructed healthcare professionals to closely monitor patients with existing stainless steel and titanium Precice devices and to report any adverse events or suspected adverse events through the agency’s MedWatch, the FDA Safety Information and Adverse Event Reporting program.