Australia’s Department of Health & Ageing issued a hazard alert for Stryker’s Oasys Midline Occipital Plate, warning patients and surgeons that the Oasys spine stabilization device might break after surgery.
The alert was based on reports of device malfunction in the U.S. and Belgium, according to MassDevice. Stryker’s Australian subsidiary jointly issued the alert, which is a less extreme step than a device recall.
Stryker’s spinal stabilization plate is part of the Oasys spinal surgery system, used in cervical and thoracic spine fusion surgery. Regulators learned that after surgery the pin connecting to the plate body could break, possibly causing patient harm and necessitating revision surgery, MassDevice reports. “The root cause of the problem is not yet known and the manufacturer is continuing to investigate reported cases from the USA and Belgium,” the Australian health agency reports. “To minimize risk to patients, Stryker Australia has removed this device from the market until the definitive root cause is identified.”
According to MassDevice, Michigan-based Stryker has faced recall issues this year and costs associated with recalls have reduced company profits. Stryker’s second-quarter profits plummeted nearly 35 percent because of costs related to the recall of the Rejuvenate hip implant. First quarter profits fell about 13 percent because of the Rejuvenate recall.