In May 2013, Stryker Orthopedics recalled a spinal plate used in cervical spinal fusion surgery. The OASYS Midline Occipital Plate has a defective pin that could fracture post-operatively. Symptoms of a defective spinal plate include pain, weakness, or numbness. Patients with these symptoms should seek emergency medical attention.
Overview
The OASYS Midline Occiput Plate is a component of the OASYS Occipito-Cervico-Thoracic System, which is used in spinal fusion surgery in the cervical (neck) and thoracic (upper-back). The purpose of the plate is to stabilize vertebrae while they fuse together.
FDA Safety Warning for Stryker Spine Plate Recall
The U.S. Food and Drug Administration (FDA) announced the Stryker spine plate recall with this warning:
“Stryker has received reports indicating post-operative fracture of the pin that connects the 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.”
Timeline of Events in Stryker Spinal Fusion Plate Recall
- April 23, 2010 — Stryker starts selling OASYS Midline Occiput Plate
- February 12, 2013 — Stryker stops selling OASYS Midline Occiput Plate.
- May 30, 2013 — The Class 1 recall was initiated when Stryker sent an “Urgent Medical Device Recall” notice to surgeons and medical facilities. They recommended immediately discontinuing use of the product.
- June 20, 2013 — Stryker recommended that patients with the OASYS spinal plate should have a follow-up evaluation that includes radiographic imaging of the spine.
- July 22, 2013 — Australian Stryker Spine Plate Hazard Alert.
- August 30, 2013 — U.S. Food and Drug Administration Stryker Spine Plate Recall.
What Stryker Spinal Products Were Recalled?
Products and manufacturing codes for Stryker spine plate recall:
- OASYS Midline Occiput Plate (Mini) — 48551048
- OASYS Midline Occiput Plate (Small) — 48551044
- OASYS Midline Occiput Plate (Medium) — 48551045
- OASYS Midline Occiput Plate (Large) — 48551046
- OASYS Midline Occiput Plate (Large Long) — 48551047
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