The U.S. Food and Drug Administration (FDA) has issued a Class 1 recall – the most serious of all recall classes – for the Stryker Oasys Midline Occiput Plate, a device used in cervical spinal fusion surgery, based on reports of post-operative fracture of a key component of the device.
The FDA first revealed the recall in an Aug. 29 safety alert to the public. The recall was based on reports that the pin connecting the tulip head to the plate body of the Stryker Oasys Midline Occiput Plate has a tendency to break following surgery. Such a fracture could lead to destabilization of the plate, and revision surgery may be required, the FDA warned in the safety alert. A host of dangerous side effects also are possible.
Revision Surgery, Blood Loss, Nerve Injury Among Potential Adverse Results
Those implanted with this device face the possibility of serious adverse health consequences, including blood loss and nerve injury, as well as the need for revision surgery to replace the fractured implant, noted the FDA’s safety alert.
Class I recalls are the most serious – involving situations “in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” the FDA noted in the safety alert. If a patient begins suffering from symptoms such as pain, weakness, or numbness, “urgent evaluation is needed,” the FDA said in the safety alert, adding that “for patients who have had a revision surgery, Stryker recommends routine post-operative care and follow-up.”
The FDA also noted that the Oasys Midline Occiput Plate is part of the Oasys System, which is used in spinal surgery to promote fusion and provide stabilization at the junction between the occipital bone and the vertebrae in the cervical and thoracic spine.
On July 22, the Australian Government’s Department of Health and Ageing issued a hazard alert regarding the Oasys Midline Occipital Plate.
Legal Help for Patients Who Have Been Implanted with Stryker’s Oasys Midline Occiput Plate
If you or a loved one have been implanted with Stryker’s Oasys Midline Occiput Plate during cervical spine fusion surgery, you may have valuable legal rights. To find out more, please fill out our online form or contact one of our experienced personal injury lawyers today at 1-800-YOURLAWYER (1-800-968-7529).