FDA warns of mechanical failures, tissue incompatibility in growing spinal rod system
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The FDA released a safety communication regarding potential mechanical failures and concerns of tissue incompatibility associated with components from a growing spinal rod system from NuVasive Specialized Orthopedics.
The devices reported in the release from the FDA include the 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 and Magec System Rods. Used in children younger than 10 years of age, the Magec devices use magnets to help correct spinal deformities as the child grows and are designed to help avoid multiple operations to correct the spinal curve.
The release noted NuVasive first recalled its Magec devices in February 2020 to address a mechanical component failure where the endcap was separating from the rod part of the device. The FDA cleared the modified version of the Magec Model X rod, designed to mitigate endcap separation events, in July 2020. In early 2021, the FDA began receiving reports that described local tissue reactions potentially related to endcap separation event with the Magec devices, according to the release. NuVasive voluntarily placed a global ship hold on all Magec devices in April 2021 due to these biocompatibility testing concerns, which was lifted on July 15, 2021.
According to the release, the FDA holds it is in the best interest of patients to make the modified Magec X device available in the United States due to the following:
- the overall benefits of the device outweigh the known risks for on-label use in the United States compared with alternative treatments;
- the U.S. indications and instructions for use, which restrict use to patients younger than 10 years old and for a 2-year implantation time, further mitigate known risks;
- the modified Magec X device, designed to mitigate endcap separation events and related biocompatibility concerns, will be the only device version currently available for sale in the United States; and
-the U.S. labeling has been updated to include a discussion of known risks associated with the device.
The FDA recommends health care providers perform a full evaluation, including radiographs, of patients presenting with unexplained symptoms of back pain, inflammation or deformity. At this time, the release noted the FDA does not recommend the removal of functioning Magec rods prior to 2 years after implantation.
The FDA noted it is working with NuVasive to evaluate additional biocompatibility testing intended to address specific theoretical biocompatibility concerns with these devices and collect additional data to better understand potential risks to patients. The FDA will also provide health care providers and patients access to an adequate supply of modified Magec devices and ensure patients with a Magec implant continue to receive appropriate follow-up monitoring. The public will continue to be informed by the FDA if significant new information becomes available.
Perspective
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David L. Skaggs, MD, MM
The use of distraction-based growing rods in the treatment of early onset scoliosis is fraught with complications. I have reported a complication rate of more than 200% using traditional growing rods that usually require surgical lengthening every 6 to 12 months throughout treatment.
Magnetic-controlled growing rods, which can lengthen without surgery, have been widely adopted by pediatric spine surgeons. They have generally lived up to the promise of fewer surgeries and comparable control of spinal deformity compared to traditional growing rods, though the rate of unplanned complications requiring surgery remains about the same. There have been many reported with the NuVasive Magec System Implants, such as mechanical component failure and not being able to lengthen the intended amount, as well as concerns about biocompatibility.
Even given these limitations, I welcome the FDA statement that “the benefits of a Magec device outweigh the risks.” This is a brave and balanced decision that will save many patients from unnecessary surgery. For some young children with spinal deformity, the only thing worse than the Magec device are all the other alternatives.
Reference:
Sankar WN, et al. Spine (Phila Pa 1976). 2010;doi:10.1097/BRS.0b013e3181c6edd7.
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