Consistent with the IFU and prior communication, this can manifest in vivo as locking pin breakage, O-ring seal failure, metal wear debris and failure of the rod to distract. Localized tissue discoloration may result from use of the MAGEC rod. Further, earlier communications indicated that a 0.5% post-implantation separation of an actuator end cap component was observed in MAGEC System Model X rods. While the system remains CE Marked, the MHRA and Health Products Regulatory Authority are undertaking a market surveillance review of MAGEC. NuVasive is working with the agencies throughout the process. The system was first implanted in 2014 under Ellipse Technologies, which was acquired by NuVasive in early 2016. The company received FDA clearance for the system later that year. MAGEC X was launched in the U.K. in 2018.