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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 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.”

 

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.”

 

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:

• pain

• weakness

• numbness

 

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.

 

If you have experienced serious side effects or know someone who is experiencing pain, weakness, or numbness due to the Stryker spinal implant, contact the defective medical device attorneys at JEFFREY KIM, P.C. to learn your legal rights and eligibility for compensation. Our firm will work with your doctor to be sure you receive the care and compensation you deserve. If you are experiencing these side effects but not sure if your spinal surgery included the Stryker OASYS implant, we can help.

 

For a no cost, no obligation initial consultation for patients and families of patients, call JEFFREY KIM, P.C.

 

FDA Report

 

TGA Report (Australian Government)