NuVasive Orthopedic Implants Recalled After Reports of Pain, Bone Changes
Federal health authorities have issued warnings to surgeons, recommending they stop implanting stainless steel Precice orthopedic devices manufactured by NuVasive Specialized Orthopedics. The warning comes just a few months after NuVasive reported that some patients had experienced pain and changes in their bones after having the devices surgically implanted.
The warning from the Food and Drug Administration (FDA) applies to Precice implants made from stainless steel, and NuVasive says it has not received negative reports from patients who received Precice implants made from titanium.
In February 2021, NuVasive voluntarily pulled three stainless steel Precice devices from the market after a series of reports of adverse reactions in those who had received the implants during surgery. Those products were:
- Precice Bone Transport
- Precice Plate
- Precice Stryde
At that time, the company also indicated that it was monitoring and would halt shipments of titanium-based Precice orthopedics devices, though it stopped short of fully removing those devices from the market. On July 8, the FDA warned surgeons to stop using Precice devices made of stainless steel and to monitor NuVasive’s investigation of its titanium Precice devices.
Precice devices made of titanium are sold under the following names:
- Precice Freedom
- Precice Intra-medullary Limb Lengthening (IMLL) Device
- Precice Short
- Precice Unyte
Reports of Adverse Reactions From Stryde Devices
Precice devices are used to lengthen, shorten or compress limbs and to transport segments of long bones. They include adjustable, implanted rods that are driven by an internal magnetic mechanism. A study published in March 2021 covering Precice Stryde devices found high rates of adverse events, including:
- Changes on X-rays (20 of 27 patients), including osteolysis (19 of 30 bone segments), periosteal reaction (12 of 30 segments) and cortical hypertrophy (12 of 30 segments)
- Late-onset pain (8 of 27 patients)
- Discoloration at site where device was removed (15 of 30 segments)
History of Precice Devices
The main device in question, Precice Stryde, is NuVasive’s third-generation limb-lengthening system designed to reconstruct limbs and lengthen stature. The company says that when used for cosmetic purposes, Stryde can increase an individual’s height by more than three inches.
Stryde has been used in patients since 2018, and NuVasive’s Precice line of products are focused entirely on orthopedics. Before it introduced Precice devices in 2011, NuVasive had focused entirely on devices used in treatment of spinal issues, including degenerative disc disease and spinal stenosis.
The Precice system works by implanting a device, or nail, into the patient’s femur, tibia or humerus. Each implanted device includes an internal gear system that is controlled remotely. This allows patients to have brief daily periods of treatment in their own homes.
What Should You Do If You Have a Precice Device Implanted?
Patients who have had Precice devices implanted, whether they were made of stainless steel or titanium, should consult with their orthopedic surgeon immediately to determine the best course of action.
Precice devices are meant to be implanted into patients for no longer than a year, so in all patients, regardless of whether they’ve had a bad reaction or not, these implants will eventually be removed.
Those who have undergone the procedure to have a Precice device implanted should closely monitor internal and external symptoms and have X-rays done to determine if the device has caused any damage to their bodies. Patients and family members of those whose bodies have been damaged by Precice devices should consider consulting with an attorney about a Nuvasive Lawsuit. Melinda J Helbock A.P.C can help them ensure their rights are protected. Contact us TODAY.