- FDA has informed healthcare providers about potential biocompatibility concerns related to NuVasive's stainless steel and titanium Precice orthopaedic devices. The devices are used to lengthen the limb, shorten or compress the limb, or transport segments of long bones.
- The agency advises physicians to stop implanting new stainless steel Precice devices. NuVasive voluntarily removed the products from the U.S. market in February after receiving adverse event reports about increased pain and bone changes.
- A voluntary recall of the titanium devices is underway and NuVasive put shipping on hold in April. The actions followed a February urgent field safety notice that discussed gaps in the data on the devices.
The field safety notice informed NuVasive customers the devices lacked data on the full set of biological assessments outlined in an ISO standard. NuVasive responded to the discovery by running assessments of carcinogenicity, chronic toxicity, developmental toxicity and reproductive toxicity.
That notice applied to the four titanium-based devices covered by the FDA alert. An earlier urgent field safety notice covered the full Precice system.
In April, NuVasive followed up with a letter telling surgeons its notified body had temporarily suspended the CE certification for "all variations of the MAGEC and Precice device systems." MAGEC, which is a system that braces the spine during growth to minimize the progression of scoliosis, was the subject of a field safety notice in December. The April letter disclosed the suspension of sales in countries requiring a CE mark and a voluntary hold on shipments to other countries.
FDA followed up with its own notice on Thursday. The agency offered different recommendations for stainless steel and titanium devices.
While FDA is advising surgeons to stop implanting stainless steel devices, its comment on titanium products was limited to a note about the voluntary recall and ship hold and a recommendation for surgeons that still have the products to follow NuVasive's advice in the February urgent field safety notice.
The different recommendations for stainless steel and titanium devices reflect the adverse event reports received by FDA. The agency has received reports of pain and changes in surrounding bone and soft tissue in patients with the stainless steel devices.
FDA said the events may be linked to wear, corrosion and unanticipated exposure to components that are undergoing biocompatibility testing. The agency is yet to receive similar reports relating to the titanium devices but is uncertain if the root cause is stainless steel or design features and materials used across all Precice devices.
FDA's notice also includes recommendations for all Precice devices. The agency is asking users to follow the U.S. labeling instructions, which advise limiting implantation to one year and following the guidance on weight-bearing.