FDA reports potential biocompatibility concerns with Precice devices
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The FDA reported potential biocompatibility concerns associated with implants from NuVasive Specialized Orthopedics that are intended to lengthen the limb, shorten or compress the limb, or transport segments of long bones.
The devices reported in a letter to health care providers from the FDA include Precice Bone Transport, Precice Plate, Precice Stryde, Precice Freedom, Precice Intra-medullary Limb Lengthening Device, Precice Short and Precice Unyte. NuVasive will perform additional biocompatibility testing on materials used for all Precice devices against updated testing standards and will conduct a series of assessments of potential mechanical failures that may contribute to biocompatibility issues, according to a press release from the FDA.
For all Precice devices, the FDA recommends that health care providers check for changes in the surrounding bone and soft tissue during routine radiographic monitoring in patients implanted with these devices. Health care providers should also perform additional radiographs and physical examination when patients have increased pain or other unexpected symptoms, with special attention to the area surrounding the “telescoping junction” of the implant. However, the FDA does not recommend early removal of non-painful, well-functioning Precice devices from asymptomatic patients prior to 1 year after implantation. Any adverse events or suspected events experienced with Precice devices should be reported to the FDA, according to the release.
The FDA reported that NuVasive voluntarily removed all stainless steel-based devices from the U.S. market as of February 2021 due to adverse events related to increased pain and bone changes and recommends health care providers stop implanting any new stainless steel-based Precice devices. NuVasive has also initiated a voluntary recall on Precice titanium-based devices, which are not being sold in the U.S. market due to a voluntary manufacturer ship hold placed in April 2021, according to the release.
The FDA noted it is working with NuVasive to evaluate new testing results to address biocompatibility issues with these devices and collect additional data to better understand the risks to patients, as well as ensure patients with a Precice device continue to receive appropriate follow-up monitoring. Health care providers and the public will continue to be informed of new or additional information as it becomes available.
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