The Food and Drug Administration issued a warning about the complications from NuVasive Precice and Styde implantation devices on July 8, 2021.
These devices are used in people 18 years of age and older. They help lengthen limbs, shorten or compress limbs, or transport segments of long bones. The adjustable rods are placed inside a patient and driven by an internal magnetic mechanism.
The models currently being monitored are the Stainless Steel (Biodur 108)-based:
- Precice Bone Transport,
- Precice Plate, and
- Precice Stryde.
As well as the Titanium-Based:
- Precice Freedom;
- Precise Intra-medullary Limb Lengthening (IMLL) Device;
- Precice Short; and
- Precice Unyte.
Painful Changes Surrounding Bone & Soft Tissue Reported
Patients who received the Stainless Steel implant have been reportedly experiencing painful changes in the surrounding bone and soft tissue of where the device was implanted in the body. The possible cause of this may be corrosion, wear, or unanticipated exposure of components in the device. As of right now, the Titanium-based devices are being monitored.
NuVasive & FDA Issue Statements & Warning
On April 5, NuVasive issued a statement that updated healthcare providers of ongoing testing with their product and placed a temporary shipment hold on all Precice devices.
The FDA is aware of adverse events related to the Precice devices and continues to monitor the situation. The recommendations currently suggest to stop implanting the new stainless steel Precise devices. As for the titanium-based ones, the FDA suggests staying on top of the recall and follow NuVasive recommendations.
All Precice models should not be implanted longer than a year, and should be adjusted accordingly for weight-bearing. The FDA says it will evaluate new testing results to address biocompatibility issues and will collect additional data to better understand the risks to patients.
Do you have a NuVasive Precice/Styde Lawsuit? Contact a Lawyer Today For a Free Case Review.
If you or someone you love has been implanted with a NuVasive Precice or Styde device, and have experienced a complication or side effect, you should contact our lawyers today. You may be entitled to financial compensation by filing a NuVasive lawsuit.
We offer a Free Case Evaluation and would be honored to speak with you. Please contact us using the form below or by calling (800) 279-6386.