While the NuVasive Magec System—a treatment for child scoliosis—remains on the market in the U.S., it has been banned in the United Kingdom (UK) because of safety concerns.
What is the Magec System?
Traditional treatment for children with scoliosis (curvature of the spine) involves inserting metal rods alongside the spine to help it grow into a straighter position. These rods have to be extended every six months or so, putting children and their parents through the stress and discomfort of multiple surgeries.
The NuVasive Magec System is made with titanium rods that contain magnets. These magnets allow a surgeon to lengthen the rods from outside the body, saving patients from additional surgeries. The system had a lot of promise early on, but recent reports indicate that serious defects in the design of the rods themselves may increase the risk of complications including rod loosening, breakage, and failure.
Nuvasive Suspends Sales in the U.K. and Ireland
On April 1, 2020, the U.K.’s Medicines and Healthcare Regulatory Agency (MHRA) warned doctors not to implant Magec rods until further notice, and to identify all patients with the implants to ensure they were still in place. According to the announcement, NuVasive voluntarily suspended the supply of all Magec rods to the U.K. to “address concerns identified by the MHRA over the continued use of the device.” The MHRA previously issued a medical device alert on the rods noting that the end cap component could separate from the housing tube after implantation.
This end cap is a threaded component designed to prevent the ingress and egress of fluid from the mechanism of the system. It may de-thread after implantation, exposing internal components to fluid. This could lead to accelerated degeneration of the mechanism and release titanium alloy wear debris.
Patients with defective Magec rods could experience tissue damage and death, metallosis, loosening, breakage, and premature implant failure. The MHRA suggested additional clinical follow-up to answer questions about the device’s potential safety issues.
NuVasive had previously issued field safety notices concerning other generations of Magec rods, alerting doctors to problems with pin breakage, O-ring seal failure, and failure of the rod to extend as expected. “These failures may result in the need for the early removal of the device and inadequate treatment,” the MHRA stated.
NuVasive Magec Rods Still Available in the U.S.
NuVasive Magec rods remain available in the U.S., even though several studies have indicated they can fail prematurely. In 2018, for instance, researchers analyzed 34 rods taken from 18 children and found titanium wear debris in all of them, with 91 percent showing measurable wear of the extending bar toward the magnet end. There was also substantial damage to the radial bearing in about three-quarters of the rods, O-ring seal failure in over half, and drive pin fracture in 44 percent
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