More Information on the FDA RECALL Stryker Spine – OASYS Midline Occiput Plate

According to the FDA, Stryker has received reports indicating post-operative fracture of the pin that connects the tulip head to the plate body. This may cause adverse health consequences including blood loss, nerve injury, and even the need for revision surgery to replace the fractured implant.

Five lots of Stryker’s OASYS Midline Occiput Plate systems were recalled due to this defect. The devices were used from April 23, 2010 through February 12, 2013. Currently, more than 1,500 of the recalled OASYS Midline Occiput Plate units are in circulation in the U.S. The recalled lots are listed below:

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

The OASYS Midline Occiput Plate is used in spinal fusion surgeries to provide stabilization at the junction between the occipital bone and the vertebrae in the cervical spine. This medical device is part of the complex OASYS Occipito-Cervico-Thoracic System used to promote fusion of the cervical spine and occipito-cervico-thoracic junction.

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

If you or a loved one has experienced complications, such as the ones listed above, please contact Keefe Law Firm immediately by calling 1-877-ATTY-24-7. Attorneys at Keefe Law Firm are available for free legal consultations to victims of alleged spinal fusion implant failures.

Keefe Law Firm handles complex medical device implant litigation throughout the nation. The firm’s offices are headquartered in Red Bank, New Jersey. For more information, please visit the firm’s defective joints website.

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