FDA alerted patients, caregivers, and providers of potential mechanical failures and biocompatibility concerns associated with components of several NuVasive's MAGEC devices, which are intended for use in children under 10 years of age.
The growing spinal rod system uses magnets to help correct correct spinal deformities as the child grows. The devices are designed to help avoid multiple operations to correct the spinal curve, and are not supposed to be implanted for more than two years.
FDA's safety notice follows NuVasive's recall in February 2020 of its MAGEC devices to address a mechanical component failure where the endcap was separating from the rod part of the device. In July 2020, FDA cleared a modified version of the MAGEC Model X rod, designed to mitigate endcap separation. Additional biocompatibility concerns related to the existing endcap failures were raised in December 2020 when NuVasive issued an updated field safety notice intended for customers in the European Union. FDA said it also began receiving reports earlier this year describing local tissue reactions potentially related to endcap separation events with the MAGEC devices.
As NuVasive continues to investigate the root cause of these issues, FDA said it is working with the manufacturer to evaluate new biocompatibility testing results and assess whether there is any clinically meaningful impact to patients with MAGEC devices.
These problems pertain to the following devices: 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.
FDA recommendations for NuVasive MAGEC patients and caregivers
FDA recommends that anyone considering a MAGEC device talk to a doctor about the benefits and risks of the device. FDA said it believes the benefits of a MAGEC device outweigh the risks for U.S. patients, based on the current FDA-cleared indicatios for use and labeling. Indications for use and labeling may vary in other countries, the agency noted.
For patients who have a MAGEC device implanted, FDA does not recommend the removal of functioning MAGEC rods prior to the two years after implantation. However, the agency said that if a patient experiences increasing levels of unexpected back pain with a MAGEC device, the doctor should perform an additional examination of the patient's back and get X-rays to evaluate the condition of the implant. Patients should also report any problems they are experiencing with a MAGEC device to their doctor, and to FDA through the MedWatch Voluntary Reporting Form.
FDA also said that decisions about removing or exchanging a MAGEC device should be made by healthcare providers in consultation with the patient and their caregivers on a case-by-case basis. Discuss with patients and their caregivers that, at this time, the FDA does not recommend removal (prior to two years post implantation) of asymptomatic MAGEC devices that are stable and well-functioning.