NuVasive Precice System Side Effects

The most common Precice stainless steel implant side effects are the possibility of device breakage and insufficient bone lengthening, according to NuVasive. In addition, the device’s safety information says metal implants like Precice may loosen, fracture, migrate, corrode or cause pain.

People who received the stainless steel Precice Stryde implant reported pain and changes in the soft tissue and bone surrounding the device, according to the U.S. Food and Drug Administration.

One 2020 study published in Acta Orthopaedica looked at the risk of complications per segment of bone lengthened with Precice. They found the overall complication rate was 31% per segment or one complication or every three segments lengthened.

But because reporting isn’t standardized, true complication rates may be different. Some studies found lower complications rates.

The Precice system is a bone lengthening device used to treat people with limb length discrepancies, meaning one limb is longer than the other. Aside from risks associated with the Precice implant, the bone lengthening procedure has its own risks.

Bone lengthening is successful in about 4 out of 10 cases, according to Mt. Sinai Hospital.

A surgeon makes a cut in the bone to be lengthened and then surgically attaches the Precice nail (rod) into the bone. The cut bone is distracted or gradually pulled apart. The body makes new bone to fill the gap, lengthening the limb. The surgeon removes the implant once the bone is strong enough.

Risks include: Allergic reactions to medicines, breathing problems, bleeding, blood clots, infections, bone growth restrictions, injury to blood vessels, poor bone healing and nerve damage.

Side effects such as pain, bone abnormalities and tissue degradation are related to potential biocompatibility concerns. Biocompatibility is the measure of how well a device does in the human body without causing a reaction, such as inflammation or device failure.

Corrosion and wear may have exposed the body to parts of the device that did not undergo biocompatibility testing, according to the FDA. Currently, the agency isn’t sure if the problems occurred because of the design and materials of all Precice implants or if the problems only affect the stainless steel implants.

NuVasive recalled all Precice stainless steel devices and put hold on the sale of titanium devices to investigate the potential cause. In December 2021, the FDA notified the public that the shipping hold on titanium devices has been lifted, but NuVasive is still investigating how issues with its stainless steel devices relate to titanium devices.

Some researchers think titanium reduces the growth of fibrous tissue around the implant and allows the implant to loosen. It may also cause inflammation, metallosis and other allergic reactions, according to a 2020 article published in Materials.

If you have a Precice implant, the FDA recommends you report any adverse events to MedWatch, the FDA Safety Information and Adverse Event Reporting program. Make sure to tell your doctor.

If you haven’t suffered any complications and your device is functional, the agency doesn’t recommend early removal. Concerned patients or parents should speak to their doctors about potential removal.

So far, the FDA hasn’t received reports of problems with titanium devices.

Implant failure and painful side effects have led several patients to file Precice lawsuits against NuVasive, claiming the device’s design was faulty. You should contact an attorney if you were injured and are interested in filing a lawsuit.