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What's the Problem with Precice Devices?
The FDA on July 8, 2021, issued a Warning Letter  stating that NuVasive Specialized Orthopedics is recalling the following NuVasive Precice System Devices over potential biocompatibility concerns:
Stainless Steel (Biodur 108)-Based Precice NuVasive Precice Implants:
- Precice Bone Transport
- Precice Plate
- Precice Stryde
Titanium-Based Precice Devices:
- Precice Freedom
- Precice Intra medullary Limb Lengthening (IMLL) Device
- Precice Short
- Precice Unyte
Related Article: Hip Implant Failure Lawsuit
"The FDA has received reports of pain and changes in the surrounding bone and soft tissue in people implanted with the NuVasive Precice Unyte System, which is stainless steel (Biodur 108)-based," FDA said. "These adverse events may be related to corrosion, wear, and unanticipated exposure of components that are undergoing compatibility testing. At this time, the FDA is uncertain if the root cause of these adverse events is due to the stainless-steel material or related to design features and materials common to all Precice plate implants."
What is the Precice Stryde Device Used For?
Precice Freedom Medical Devices are indicated for those 18 years of age and older and are used to lengthen the limb, shorten or compress the limb or transport segments of long bones. The NuVasive Precice System includes adjustable rods that are placed inside a patient and are driven by an internal magnetic mechanism.
Other NuVasive Cases We've Taken: Magec Rods Lawsuit
What is Biocompatibility?
Potential biocompatibility concerns refer to how the materials and components of a medical device should interact with your body and its biological responses. Any medical device that comes in contact with the human body, either directly or indirectly, is required to undergo biocompatibility testing to determine the:
- Overall safety of the product
- Potential for adverse biological responses
Side Effects of Bio-incompatibility
When a medical device has not been properly tested for biocompatibility, it could end up causing harm. Complications from a device that is not biocompatible may include:
- Bone abnormalities
- Developmental effects
- Reproductive system effects
- Skin irritation or burns
Patients with stainless steel Precice devices have reported pain and changes in surrounding bone and soft tissue. According to the FDA, these side effects may be related to corrosion, wear, and previously unanticipated exposure of components.
In the FDA’s letter to healthcare providers, the agency said it is working to evaluate new testing to address biocompatibility issues. NuVasive and the FDA are working together to collect more data that can provide insights into the causes of the complications and to make sure patients who currently have a recalled Precice device and external remote control are properly monitored.
At this time, the FDA is not recommending the early removal of devices in people who are not experiencing any reactions to their current stainless steel Precice devices. The agency does urge patients and their doctors to check for changes “during routine radiographic monitoring” and pay close attention to any unexpected symptoms, such as pain.
So far, the FDA hasn’t received reports of biocompatibility issues stemming from titanium-based Precice devices. NuVasive is currently investigating these devices for potential connections to the adverse events seen with stainless steel devices.
While titanium is known for its favorable biocompatibility, implants made with this metal also have some disadvantages, according to a 2020 study published in Materials.
“These include low biologic activity, which reduces the growth of fibrous tissue and allows loosening of the prosthesis, the possibility of metallosis and related inflammation or other allergic reactions, as well as abrasion of the material during operation,” the researchers concluded.
Nuvasive Recall Timeline
- February 2021 - NuVasive issued a nationwide recall for their stainless steel Precice System devices after patients reported pain and changes in the bone tissue around the device, including bony abnormalities between the nail segments.
- April 2021 - NuVasive initiated a recall and manufacturer ship hold on their titanium Precice devices, since the company is unaware of the cause of adverse events in the stainless steel products.
- July 8, 2021 - FDA flagged concerns over biocompatibility with NuVasive Precice devices and urged healthcare providers to monitor recipients.
Which Serious Injuries Are Patients Suing NuVasive Over?
Injuries related to biocompatibility are the main focus of Precice lawsuits, which include tissue reactions, bone problems and other complications stemming from the body reacting poorly to the implant.
A 2021 study published in Acta Othropaedica found that patients with Stryde implants had pain and abnormal bone growth at the nail junction. The researchers found 20 out of 23 retrieved nails had corrosion / discoloration, and also found biological material inside the nail.
The study's authors concluded that the design of the screw holes and locking screws may have contributed to the patients’ health problems.
NuVasive is investigating potential health problems, such as cancer, chronic toxicity, developmental toxicity and reproductive toxicity, linked to biocompatibility problems with its Precice devices.
People with the following injuries may qualify to file a Precice Bone Transport Lawsuit:
- Bone abnormalities
- Bone degradation
- Developmental effects
- Reproductive system problems
- Skin irritation or burns
- Tissue death (necrosis) around the implant
- Tissue degradation
FDA Recommendation on Nuvasive Medical Devices
For patients implanted with any of the above devices, doctors should check for changes in the surrounding bone and soft tissue during routine radiographic monitoring.
When patients have increased pain or other unexpected symptoms, doctors should perform additional radiographs and physical examination, with special attention to the area surrounding the telescoping junction of the implant.
"At this time and based on currently available information, early removal of non-painful, well-functioning Precice devices from asymptomatic patients prior to one-year post implantation is not recommended," FDA said. "Decisions about removing or exchanging the Precice device should be made by health care providers in consultation with the patient or caregiver on a case-by-case basis."
Related: All Medical Devices Lawsuits That We've Covered
Get a Free Nuvasive Precice Lawsuit Evaluation With Our Lawyers
The Defective Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Precice Stryde Lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.
If you or a loved one was injured by a Nuvasive Precice device, you should contact our law firm immediately for a free review. You may be entitled to a settlement by filing a NuVasive Precice System Lawsuit and our lawyers can help.