According to reports, Stryker learned that a post-operative fracture can occur in the pin that connects the tulip head to the plate body (see image). The scenario could cause serious adverse health consequences, including blood loss, nerve injury, and the need for revision surgery to replace the fractured implant.
Class I recalls are reserved for such situations in which there is a reasonable probability that the product will cause serious adverse health consequences or death.
The plate is part of the OASYS Occipito-Cervico-Thoracic System that is used to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput – T3). The plate provides stabilization at the junction between the occipital bone and the vertebrae in the cervical spine.
The affected products (listed below) were distributed from April 23, 2010 through February 12, 2013. Currently, 1,536 units are in commerce in the U.S. with another 880 abroad.
According to a statement from Stryker’s Spine division, the company instructed all U.S. registered OASYS System surgeons to discontinue use of the Midline Occiput Plate in February 2013.
According to the FDA, Stryker issued an Urgent Medical Device Recall on May 30, 2013, requesting medical facilities to examine their inventory and immediately stop distributing or using the recalled lots and any remaining product should have been returned to the company.
On June 20, 2013, the company reached out to spinal implant surgeons and recommended routine clinical and radiographic post-operative evaluation for patients implanted with the particular plate. More evaluation is required in any patient experiencing pain, weakness, or numbness and for the patients who have had a revision surgery, Stryker recommended routine post-operative care and follow-up.
Health care professionals and consumers can report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by mail, or by FAX.
The products affected include:
- 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