Concerns In Relation To Roads Used On Earlier Versions Of Device

Medical device manufacturer Ellipse has issued an advisory statement in relation to safety concerns regarding rods used on earlier designs of its MAGEC Spinal Bracing and Distraction System.

In its latest Field Safety Notice, the company has outlined how some specific lot numbers of the product – used to limit motion in those suffering from back pain and injuries – may feature rods which are more prone to fracture at the welded actuator portion.

Ellipse explained that since its launch in November 2009, changes have subsequently been made to the design and performance of the device – particularly in relation to the weld inspection and manufacturing process.

The manufacturer has stressed it is not recommending the replacement of the rods, but calling on medical professionals to closely monitor patients until treatment is complete.

Details of the product lots thought to be affected by the issue are available on the company website.

Expert Opinion

While it is welcome that steps have been taken to address the safety concerns raised in relation to early version of this device, it is of course worrying that those initial products affected by the issue were still deemed suitable for use. <br/> <br/>"We have long-held concerns regarding the regulatory framework that medical devices must pass through in order to reach market, after seeing numerous cases in which patients have suffered injury or illness as a result of defective products. <br/> <br/>"Anyone fitted with a medical device expects it to aid their treatment and recovery, yet we have seen how many people can go on to endure significant suffering which has an impact on their physical and mental wellbeing. <br/> <br/>"It is vital that the current regulatory process is seriously examined to ensure it is fit for purpose."