The FDA released a letter to healthcare providers warning about potential biocompatibility concerns associated with NuVasive Specialized Orthopedics’ Precice devices made from stainless steel and titanium. The FDA sent a second letter adding MAGEC System Implants to the list of recalled devices.
NuVasive started biocompatibility testing after the FDA received reports of pain and changes in surrounding bone and soft tissue in patients with the stainless steel-based devices, which includes the following:
Specialized Orthopedics’ MAGEC devices:
- MAGEC Spinal Bracing and Distraction System
- MAGEC 2 Spinal Bracing and Distraction System
- MAGEC System
- MAGEC System Model X device
- MAGEC System Model X rod
- MAGEC System Rods
Stainless Steel (Biodur 108)-Based Precice Devices:
- Precice Bone Transport
- Precice Plate
- Precice Stryde
NuVasive Precice devices are implants intended for patients over age 18 with limb length discrepancy. The devices include adjustable rods driven by an internal magnetic mechanism to lengthen the limb, shorten or compress the limb, or transport segments of long bones.
Pain or Bone Damage From NuVasive Precice Stainless Steel Devices or MAGEC System Implants
If you have experienced any of the following symptoms, contact our medical product liability attorneys today. You may be owed money damages in compensation:
- Ongoing pain
- Tissue damage near your surgery site
- Been told you may have damage or other changes to your bone
- Been told you may have metallosis (metallosis is a build up of metal debris in the body that can poison surrounding tissue)
Contact the Pritzker Hageman Medical Product Legal Team
Phone: 888-377-8900 | Text: 612-261-0856
The consultation is 100% free and you never pay us anything ever unless we collect money damages for you
As of February 2021, NuVasive voluntarily removed all stainless steel-based devices from the U.S. market because of reports of pain and changes in surrounding bone and soft tissue, which may be related to corrosion, wear, or previously unanticipated exposure. At this time, it is unclear whether the root cause of these adverse events is from the stainless-steel material or related to design features and materials.
The FDA recommends that healthcare providers stop implanting any new stainless steel-based Precice devices and monitor for changes in the surrounding bone and soft tissue during routine radiographic monitoring of patients who already received these devices. Additional radiographs and physical examination with special attention to the area surrounding the telescoping junction of the implant should be performed when patients report increased pain or other unexpected symptoms.
MAGEC System Implants FDA Recommendations
Talk to a doctor about the benefits and risks of the MAGEC device. The FDA believes the benefits of a MAGEC device outweigh the risks for U.S. patients based on the current FDA-cleared indications for use and labeling. Indications for use and labeling may vary in other countries.
At this time, the FDA does not recommend the removal of functioning MAGEC rods prior to the two years after implantation.
The FDA is working with NuVasive to evaluate new testing results to address biocompatibility issues, collect additional data to better understand the patient risk, and ensure that all patients with a Precice device continue to receive follow-up monitoring.
Medical Product Liability Lawyers
We help people who are critically injured by unsafe medical products get the justice and full compensation they deserve. Our law firm has been representing people injured by defective medical products for the past 40 years. Pritzker Hageman was awarded a “Best Lawyers in America” award in mass tort litigation for our work representing clients with failed hip and knee implants.
If you would like to talk to a lawyer about your case, please call 1-888-377-8900, text 612-261-0856, or fill out the form below. Consultations are free and there is no obligation. A recall is not necessary to file a lawsuit and win a settlement.