Monday, September 30, 2013

FDA Issues Recall On Stryker Spinal Plate Implants

The U.S. Food and Drug Administration (FDA) has issued a recall on the Stryker Spine OASYS Midline Occiput Plate, due to a defect that can cause dangerous side effects. The plate is commonly used as an implant in spinal surgeries, but fractures in the pin that connects the implant’s head to the plate body have been reported recently. These fractures can cause serious side effects such as blood loss, nerve injury and a need for revision surgery.
The FDA issued a Class 1 recall on the plates, the most serious type of recall that can be issued, claiming there is a “reasonable probability” that using the products could lead to “serious adverse health consequences or death.”
Products made by Stryker that were reported to possibly have fractures were distributed between April 23, 2010 and February 12, 2013. It is estimated the 1,536 units exist in the U.S. and another 880 internationally.
This is not the first time Stryker has recalled a dangerous medical device. In 2009, Rejuvenate and ABG II modular-neck hip stems were recalled due to corrosion at the modular neck junctions. The stems are metal hip implants that led to toxic metal debris entering the blood stream.
The FDA does not have the same regulations for medical devices as they do for pharmaceuticals. Many medical devices make it through the approval phase without being properly tested. When devices such as these implants are defective and inserted into patients, catastrophic injuries and even death can occur.