Ellipse Issues Alert On MAGEC Spinal Bracing And Distraction System

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.