On August 29, 2013, the FDA and Stryker notified healthcare providers of a class I recall of Stryker’s OASYS Midline Occiput Plate. This most serious type of recall was issued because of reports of fracture of the pin that connects the implant’s head to the plate body.
According to their website, Stryker is one of the world’s leading medical technology companies. Their spine products are created to help people lead “more active and more satisfying lives”. The OASYS Midline Occiput Plate is a part of Stryker’s OASYS system for spinal surgery. The OASYS system was “developed to provide the surgeon with unsurpassed versatility for the treatment of pathologies” related to the spine.
Because of the defect in this part, there are serious adverse health consequences that are associated due to the failed OASYS Midline Occiput Plate. These problems include nerve injury and the need for revision surgery to replace the fractured implant. According to the FDA, the affected products were distributed from April 23, 2010, through February 12, 2013. The following parts were identified as those affected by the recall:
|
Manufacturing Part Number |
Product Description |
| 48551044 | OASYS MIDLINE OCCIPUT PLATE, SMALL |
| 48551045 | OASYS MIDLINE OCCIPUT PLATE, MEDIUM |
| 48551046 | OASYS MIDLINE OCCIPUT PLATE, LARGE |
| 48551047 | OASYS MIDLINE OCCIPUT PLATE, LARGE LONG |
| 48551048 | OASYS MIDLINE OCCIPUT PLATE, MINI |
Stryker first knew about the issue on May 30, 2013. Stryker first issued an Urgent Medical Device Recall requesting hospitals to examine the affected OASYS midline occiput plate parts and to immediately stop using the recalled materials. On June 20, 2013, Stryker notified spinal implant surgeons recommending routine clinical and radiographic post-operative evaluation for patients with an implanted OASYS Midline plate.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of medical devices to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
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