FDA Issues Letter To Doctors About Issues with NuVasive Precice Limb-Lengthening Devices
U.S. health regulators have issued an updated warning and information for doctors about possible side effects of NuVasive Precice limb-lengthening titanium adjustable rods, which have been linked to biocompatibility issues in the past.
The U.S. Food and Drug Administration (FDA) provided information about the continuing evaluation of the NuVasive Precice Limb Lengthening problems on June 28, reminding doctors that the devices should be removed after one year.
The new information follows a series of prior NuVasive recalls or warnings about potential safety signals, indicating that the agency is still monitoring adverse events related to potential biocompatibility problems with the NuVasive Precice Intra-medullary Limb Lengthening (IMLL) system, which includes Precice Short.
The NuVasive Precice IMLL system is an orthopedic system used to lengthen the shin (tibia) or thigh (femur) bones.
Precice devices are implants intended to lengthen the limb, shorten or compress the limb, or transport segments of long bones. The devices include adjustable rods placed inside a patient, which are driven by an internal magnetic mechanism that leads to lengthened or shortened bones.
NuVasive Limb-Lengthening Implant Problems
In 2021, the FDA issued a recall of NuVasive stainless steel-based Precice devices, due to biocompatibility concerns, and warned at that time that certain devices should not be implanted.
The FDA received reports of patients suffering from adverse health effects after the stainless steel devices were implanted. Side effects included bone and soft tissue changes around the implant area.
In 2021, the FDA also warned doctors about mechanical failure problems and tissue incompatibility concerns linked to NuVasive MAGEC spinal rod systems. The warning was issued after multiple reports of end caps separating from the rod were received. The rod is part of a spinal rod system intended for use in children under 10 years of age.
Updated NuVasive Precice Implant Warnings
In March 2023, NuVasive received FDA 510(k) clearance for expanded use of the Precice IMLL system, including the Precice Short, for use in patients older than 12 years old.
The IMLL system is intended for limb lengthening for patients 18 years and older, including open and closed fracture fixation, pseudarthrosis, malunions, nonunions, or bone transport of long bones use, and limb lengthening of the femur and tibia for patients older than 12 years old.
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While the previous problems affected steel-based implants, the FDA is not aware of reports of adverse events linked to titanium-based Precice devices and continues to monitor biocompatibility concerns.
The FDA update includes a strong reminder for doctors to remove the IMLL devices after one year. In addition, the agency warns that health care professionals should not implant these Precice devices in patients under 50 pounds or over the maximum patient weight described in the instructions.
The agency also warns doctors not to implant more than two Precice devices in a patient at once, and that they should be removed after one year.
The agency urges doctors and patients to report any side effects linked to any NuVasive Precice IMLL systems to the FDA MedWatch Adverse Event Reporting System.
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