FDA: NuVasive Precice Devices May Cause Pain, Bone Changes in Patients

NuVasive Precice implants used in limb-lengthening, fracture fixation, and transportation of long bones procedures may put implant recipients at risk for increased pain and changes in the bone and soft tissue surrounding the implant, according to a new FDA warning. On July 8, 2021, the agency issued a letter to healthcare providers warning about potential biocompatibility concerns associated with Precice System devices made from stainless steel and titanium. If you or someone you love received a NuVasive Precice implant and has experienced pain, bone changes, or other serious side effects, you may be entitled to compensation for your injuries. Contact us today to learn more about the possibility of filing a Precice injury lawsuit against NuVasive Specialized Orthopedics.

Potential Biocompatibility Issues with Precice Implants

Nuvasive’s Precice System is used to lengthen limbs, shorten or compress limbs, or transport segments of long bones in adults 18 years of age and older who have limb length discrepancies. The devices are made from stainless steel and titanium and are comprised of a telescoping rod that can be gradually adjusted via an external remote controller until the desired limb length is achieved. However, NuVasive has stopped shipments of its Precice implants due to problems with biocompatibility, a term that refers to the potential for certain medical devices to have an “unacceptable adverse biological response resulting from contact of the component materials of the device with the body.”

According to the FDA, medical devices that come into “direct or indirect contact with the body” must be evaluated for biocompatibility in order to protect patients from potential adverse health effects. The NuVasive implants associated with these biocompatibility concerns include the Precice Bone Transport, Precice Plate, and Precice Stryde stainless steel (Biodur 108)-based devices and the Precice Freedom, Precice Intra-medullary Limb Lengthening (IMLL) Device, Precice Short, and Precice Unyte titanium-based devices. According to the FDA warning, the agency has received reports of pain and changes in surrounding bone and soft tissue in people implanted with the stainless steel-based Precice devices. The FDA reports that these side effects “may be related to corrosion, wear, and previously unanticipated exposure of components that are undergoing biocompatibility testing.”

Precice Devices Removed from U.S. Market

Due to reports of adverse events related to potential biocompatibility issues, NuVasive removed all stainless steel-based Precice devices from the U.S. market in February 2021 and placed a global ship hold on all stainless steel and titanium Precice implants in April 2021. Due to the risk of potential biocompatibility issues, the FDA has instructed healthcare providers to stop implanting any new stainless steel Precice devices in patients. “For patients implanted with these devices, check for changes in the surrounding bone and soft tissue during routine radiographic monitoring,” the FDA advises in its letter to healthcare providers. “When patients have increased pain or other unexpected symptoms, perform additional radiographs and physical examination, with special attention to the area surrounding the telescoping junction of the implant.”

NuVasive Conducting Additional Biocompatibility Testing

It has not been determined whether the underlying cause of these adverse events is due to the stainless-steel construction of the Precice implants or to design features and materials that are present in all Precice implants. Therefore, while there are no known reports of biocompatibility-related injuries or side effects associated with the titanium-based Precice implants, NuVasive has initiated a voluntary recall for these devices, and due to the ship hold, they are not being sold in the U.S. In the meantime, “NuVasive is performing additional biocompatibility testing on materials used for all Precice devices against updated testing standards,” the FDA reports. “NuVasive is also conducting a series of assessments of potential mechanical failures that may contribute to biocompatibility issues.”