A review of the potential safety risk posed by faulty Magec rods by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has seen manufacturer NuVasive suspend the supply of the device to the UK and Ireland.
In an urgent field notice from NuVasive to healthcare providers on April 1, the manufacturer recommends that no Magec rods are implanted in the UK or Ireland while the review is carried out.
A safety notice issued in February had recalled all of the Magec System Model X rods, this was due to an issue being identified involving the separation of an actuator end cap component in the rods.
After seeking advice from clinical experts, MHRA says that it is recommended that all patients implanted with the Model X receive an anteroposterior X-ray within the next three months, while patients with any Magec device should be advised about possible complications and alternative treatment options.
Regarding the suspension, NuVasive issued a statement: “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.”
For the duration of the review, Magec rods will only be implanted in the UK and Ireland in cases deemed essential and with approval from the MHRA or HPRA.