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MAGEC system product recall makes way for potential product liability claims

Posted: 01/06/2020

A MAGEC system is a commonly used medical device, particularly within spinal surgery. It is used to brace the spine during growth to minimise the progression of scoliosis. Many of the patients that undergo this treatment are paediatric patients.

Following reports of post-implantation separation of an actuator end cap in MAGEC system Model X rods, a safety notice was issued on 13 February 2020. Physicians were told to halt all implantations of the system, as the data reviewed showed that the actuator end cap separation had occurred in approximately 0.5% of the devices. NuVasive, the manufacturer, stated: “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.”

Physicians have been advised that the implant may loosen, corrode, migrate or cause pain and the rod may continue to lengthen/distract while serving as an internal brace after the separation of the end cap. This could lead to exposure of the internal components of the actuator, which could cause hastened degeneration of the internal components and egress of titanium alloy, wear debris and resultant localised tissue discolouration.

The long-term practical ability of a rod that has separated from an end cap to perform its original function is currently unknown. The root cause of the separation is under investigation.

At present, no revision surgery is being recommended if separation has occurred, but if separation is detected and confirmed whilst undergoing a routine follow-up appointment, removal of the device may be suggested. It is strongly advised that this decision would be down to the consultant undertaking the review. If it is recommended by the physician to undergo a revision, they must properly counsel and seek consent from any patient and their family, taking into account potential issues with the revision. If it is deemed sensible to remove the rod, physicians must ensure all associated accessories and the device are removed and returned to NuVasive (the device manufacturer).

It is recommended to use and review details provided by the Medicines and Healthcare Products Regulatory Agency to understand how to identify if the end cap has been separated using a post-operative X-ray. A copy of the notice should also be passed to anyone within the hospital that should be informed of the safety announcement. Physicians have been told to identify all patients who have this implant and perform an X-ray within three months from March 2020 (by June 2020) to determine if a patient has suffered from the separation. Patients must be advised of the complications as a result of the issue and on the alternative treatment options available to them.

As a result of the current Covid-19 pandemic, follow-up appointments have been delayed. However, physicians are still expected to complete risk assessments on behalf of each patient concerned in order to ensure those who are in need of an appointment are seen in any event.

If you think you may have been affected by this issue, or have undergone surgery to insert a MAGEC system and have not yet been contacted by your physician, please call them for advice. If you think you may have suffered injury as a result of this product, our specialist team may be able to assist.

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