NuVasive issued an urgent field safety notice Feb. 13 recalling its Magec System Model X rods for patients with early onset scoliosis.
The Magec system braces the spine during growth to minimize the progression of scoliosis.
The system is being investigated after separation of an actuator end cap component was reported in 0.5 percent of Magec devices post-implantation.
The separation of the end cap could lead to degenerated internal components and egress of titanium alloy wear debris, resulting in tissue discoloration.
The company is advising spine surgeons to perform clinical follow-ups and discuss potential risks with patients who received the affected rods.
NuVasive provided the following statement to Becker's:
"First and foremost, NuVasive's priority is the safety of our patients and the ability to support our patients and surgeon partners. Through our post-market surveillance processes, we learned that in certain cases, Magec X rods experienced a post-implantation separation of an actuator end cap component.
"Although there was a relatively low rate of endcap migration, on Feb. 13, 2020, the company chose to voluntarily recall its Magec X model rods as patient safety is our highest priority."