FDA: Recalled Stryker spinal surgery device is potentially deadly

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by Michael Heygood

Stryker Corporation first issued a voluntary recall of its Oasys Midline Occiput Plate earlier this year. The plate is part of the company’s Oasys Occipito-Cervico-Thoracic System used for fusion of the cervical spine at the occipito-cervico-thoracic junction, between occiput and T3, according to the FDA release. When using the system, stabilization occurs at the junction and between the occipital bone and the vertebrae in the cervical spine.

The device was recalled in May after reports that a pin that connects the implant’s tulip head to the plate body can fracture, potentially causing blood loss, nerve injury and the need for surgery to replace the fractured implant. In May, Stryker urged medical facilities to examine inventory and immediately stop distributing or using the recalled device. Then, in June, Stryker notified spinal implant surgeons that it recommended routine clinical and radiographic post-operative evaluation for patients with an implanted OASYS Midline plate.

The FDA has assigned its most serious label, Class 1, to the recall which indicates that a malfunctioning component of the spinal surgery device could have deadly consequences. “Class 1” FDA recalls are for dangerous or defective products that predictably could cause serious health problems or death. According to the FDA, examples of a Class 1 recall would include food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.

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