Stryker Spine has issued a Class I Recall of its OASYS Midline Occiput Plate.
Stryker Recalls Spine Plate
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Secondary
The recall follows a July Hazard Alert for the device from Australia’s regulatory agency, the Therapeutic Goods Administration.
On August 29, 2013, the FDA posted the recall on its Medical Device website. According to the FDA, the recall was initiated May 30, 2013 and affects products that were distributed from April 23, 2010 through February 12, 2013.
Stryker 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.
The Australian alert said the root cause of the problem is not yet known and Stryker is continuing to investigate reported cases from the U.S. and Belgium. At the time of the hazard alert, no cases of this problem had been reported in Australia.
Urgent Medical Device Recall
The FDA commented that Stryker issued an Urgent Medical Device Recall on May 30, 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.
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
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.
The OASYS Midline Occiput Plate is part of the OASYS Occipito-Cervico-Thoracic System used to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput – T3). The OASYS Midline Occiput Plate provides stabilization at the junction between the occipital bone and the vertebrae in the cervical spine.
Class I Recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Questions should be directed to Michelle Barry, Stryker Regulatory Compliance Manager at 201-760-8287 or by email at michelle.barry@stryker.com.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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