The Food and Drug Administration has issued a Class 1 Recall on Stryker Spine – OASYS Midline Occiput Plates due to reports of fracture of the pin that connects the implant’s tulip head to the plate body. This may cause serious adverse health consequences including blood loss, nerve injury, and the need for revision surgery to replace the fractured implant.
According to a FDA release, the OASYS Midline Occiput Plate is part of the OASYS Occipito-Cervico-Thoracic System used to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput – T3). The OASYS Midline Occiput Plate provides stabilization at the junction between the occipital bone and the vertebrae in the cervical spine.
A Class 1 Recall is the highest action taken to remove a product from the market because there is a reasonable probability that use of the product will cause serious adverse health consequences. In this instance, consequences including blood loss, nerve injury, and the need for revision surgery to replace the fractured implant.
The products implicated in the recall were distributed from April 23, 2010, through February 12, 2013. Patients are reporting symptoms such as pain, weakness, or numbness.
As stated on the FDA’s website, Stryker issued an Urgent Medical Device Recall on May 30, 2013 requesting that all medical facilities examine their inventory and immediately stop distributing or using the recalled lots. If a medical facility has the affected product in stock, it should immediately stop using and return to Stryker. For patients who have had a revision surgery, Stryker recommends routine post-operative care and follow-up.
You should consult with a doctor if you have any ongoing symptoms or health concerns from a Stryker OASYS Midline Occiput Plate. If you have significant injuries, you should also consult with a Lopez McHugh attorney to discuss your legal rights.
