A Class I recall has been issued in the United States for the OASYS Midline Occipital Plate, part of the OASYS Occiptito-Cervico-Thoracic System. The device is used in cervical spinal fusion surgery. Class 1 recalls are the most serious, which the FDA says are “situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences” and for some products, death.
Stryker, manufacturer of the device, issued the recall after receiving reports “indicating post-operative fracture of the pin the 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.”
Reports of the device defects have prompted other countries to take action:
The root cause of the problem is not yet known and the manufacturer is continuing to investigate reported cases from the USA and Belgium,” according to the Australian Department of Health and Ageing. “To minimize risk to patients, Stryker Australia has removed this device from the market until the definitive root cause is identified.
Health care professionals notified, OASYS to be removed from medical device inventories
According to the FDA report, in June 2013, Stryker notified spinal implant surgeons recommending routine clinical and radiographic post-operative evaluation for patients with an implanted OASYS Midline plate.
Symptoms that may indicate failure of the device:
Patients with these symptoms are urged to contact their doctor for an evaluation. Patients who have already had the defective device removed and undergone revision surgery, should seek “routine post-operative care and follow-up” according to Stryker.
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