Stryker Spine: Class 1 Recall - OASYS Midline Occiput Plate

[Posted 08/29/2013]

AUDIENCE: Orthopedic Surgery, Risk Manager

ISSUE: FDA and Stryker notified healthcare professionals of a class 1 recall 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.

BACKGROUND: On May 30, 2013, Stryker issued an Urgent Medical Device Recall requesting medical facilities to examine their inventory and immediately stop distributing or using the recalled lots. If a medical facility has the affected product in stock, it should be returned to Stryker.

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.

RECOMMENDATION: If a patient begins experiencing symptoms including pain, weakness, or numbness, urgent evaluation is needed. For patients who have had a revision surgery, Stryker recommends routine post-operative care and follow-up.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178