NuVasive is investigating biocompatibility issues with PRECICE implants after dozens of reports of pain, bone changes, corrosion, and other severe side effects.
Need a Texas NuVasive PRECICE Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with a severe side effect of a recalled NuVasive PRECICE Device, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
UPDATE: NuVasive Announces Recall to Update Label for PRECICE Implants
On November 30, 2021, NuVasive and the FDA announced a recall for titanium-based PRECICE implants to notify healthcare providers of an updated label for the following devices:
- Precice Freedom
- Precice Intra-medullary Limb Lengthening Device
- Precice Short
- Precice Unyte
The new label will clarify that PRECICE devices are only for patients over 18 who weigh at least 50 lbs, and that no more than 2 devices should be implanted at a time.
FDA Letter Warns Doctors of Problems With NuVasive PRECICE Implants
In July 2021, the FDA issued a Letter to Health Care Providers, warning about biocompatibility problems with NuVasive PRECICE devices. The FDA said it “has received reports of pain and changes in the surrounding bone and soft tissue in people implanted with the Precice Stryde device, which is stainless steel (Biodur 108)-based.”
List of NuVasive PRECICE Implants
Stainless Steel (Biodur 108)-Based Precice Devices:
- Precice Bone Transport
- Precice Plate
- Precice Stryde
Titanium-Based Precice Devices:
- Precice Freedom
- Precice Intra-medullary Limb Lengthening (IMLL) Device
- Precice Short
- Precice Unyte
What is the Problem?
NuVasive issued a recall for all titanium PRECICE implants in February 2021. NuVasive also pulled all stainless steel-based PRECICE devices off the market in the U.S. due to safety concerns.
NuVasive said the recall was issued due to “reports of pain and bony abnormalities at the interface between the telescoping nail segments.”
The FDA said the root cause of the problems may be related to “corrosion, wear, and previously unanticipated exposure of components that are undergoing biocompatibility testing.”
NuVasive Stops Global Shipments of PRECICE Implants
After warning doctors of possible biocompatibility problems, NuVasive halted global shipments of PRECICE implants in April 2021 while the devices undergo further testing to investigate what is causing so many patients to experience pain and other problems. In some cases, patients have needed surgery to remove their PRECICE implant.
Side Effects Linked to PRECICE Implants
- Bone changes
- Bone loss (osteolysis)
- Abnormal bone growth
- Surgery to remove the implant (revision surgery)
- And more
What is the PRECICE System?
NuVasive Specialized Orthopedics manufactures the PRECICE System, a range of orthopedic devices that are implanted in patients to lengthen limbs, shorten or compress limbs, or transport segments of long bones. The PRECICE System consists of rods (or “nails”) that are adjustable with a remote-controlled magnetic mechanism.
Studies Find Dozens of Reports of NuVasive PRECICE Failures
The PRECICE Stryde Limb Lengthening Implants have been linked to dozens of reports of pain, bone changes, corrosion and other types of bad reactions. Many patients needed surgery to remove the implants.
For example, a study in March 2021 involving 27 patients discovered very high rates of pain and bone problems. The authors of the study concluded: “We recommend removal of Stryde implants as early as possible after consolidation of the regenerate.”
Another study of 8 patients, published in June 2021, found that most of the patients suffered from “localized pain and swelling,” as well as bone loss and bad reactions, like “osteolysis and periosteal reaction at the junction of the telescopic nail.”
In June 2021, a study found that 20 out of 23 STRYDE implants (87%) had corrosion at the locking screws and screw holes. The investigators were also concerned about finding “biological material inside the nail … in addition to oozing from the junction of 2 nails.”
Need a NuVasive PRECICE Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our law firm for a free case review.