NuVasive has lifted a U.S. voluntary ship hold on its Magec system and made a modified Magec X device available for sale, effective July 15.
The Magec X rods, designed for the treatment of early onset scoliosis, were recalled in February 2020 after a separation of an actuator end cap component was reported in some Magec devices post-implantation, which could lead to degenerated internal components and egress of titanium alloy wear debris, resulting in tissue discoloration.
In July 2020, the FDA cleared a modified version of the Magec Model X rod to address separations of the end cap, but further biocompatibility concerns potentially related to the endcap failures were raised in December 2020 when NuVasive issued an updated field safety notice for European customers, according to the FDA.
Earlier this year, the FDA began receiving reports describing local tissue reactions potentially related to endcap separation in Magec devices.
After noting potential concerns with the device, the FDA said it believes "it is in the best interests of patients to make the modified Magec X device available in the U.S. because the overall benefits of the device outweigh the known risks for on-label use in the U.S. compared to alternative treatments and the U.S. indications and instructions for use — which restrict use to patients less than 10 years old and for a two-year implantation time — further mitigate known risks."
The modified Magec X device will also be the only device version currently available for sale in the U.S., and the labeling has been updated to include a discussion of known risks associated with the device in the U.S.
NuVasive continues to investigate the root cause of the issues and is working with the FDA to assess new biocompatibility testing results and determine whether there is any clinically meaningful impact to patients with Magec devices.
The FDA has informed patients and providers about potential mechanical failures and tissue incompatibility concerns associated with the following products developed by NuVasive Specialized Orthopedics:
- 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
Patients experiencing issues with an implanted Magec device are encouraged to report the problem to their provider and the FDA through the MedWatch Voluntary Reporting Form.