NuVasive has suspended the supply of all Magec rods to the UK and Ireland while the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) reviews the continued use of the device.
An urgent field safety notice issued by the manufacturer to healthcare providers on 1 April recommends that no Magec rods are implanted in either country while the review is ongoing. The action follows a safety notice, issued in February, recalling all of Magec System Model X rods due to the identification of an issue involving the separation of an actuator end cap component in the device.
The Magec System is used to brace the spine during growth to minimise the progression of scoliosis. The end cap is a threaded component which is designed to prevent the ingress and egress of fluid from the mechanism of the system. According to MHRA, the component may de-thread after implantation, which could lead to accelerated degeneration of the mechanism and release of titanium alloy wear debris. This issue affects only the MAGEC Model X device generation.
In an alert published on its website, MHRA said it has sought expert clinical advice that recommends all patients to have been implanted with the Model X version of the device receive anteroposterior X-ray imaging within the next three months.
Additionally, patients with any generation of the Magec system should be advised about the possible complications resulting from the device, and informed what alternative treatment options are available.
NuVasive issued the following comments in relation to the action: “Our ability to safely support our patients and the healthcare community is of highest priority.
“NuVasive issued a voluntary Field Safety Notice on 1 April informing surgeons in the United Kingdom (UK) and Republic of Ireland (ROI) that the MHRA and HPRA are performing a market surveillance review of the Magec System, as a follow up to the Magec X recall in Feb 2020.”
The company added that, while the review is ongoing, Magec rods will only be implanted in the UK and ROI by approval from the MHRA or HPRA in cases where a surgeon deems its use to be essential.
“The Magec System is recognised as a key and established device for treating early onset scoliosis, and we are committed to ensuring surgeons and patients have access to this technology,” it said.