The FDA Issues Class 1 Recall for Stryker’s Oasys Midline Occiput Plate Due to a Key Defect, Reports Parker Waichman LLP

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The U.S. Food and Drug Administration has issued a Class 1 recall – the most serious of all recall classes – for the Stryker Oasys Midline Occiput Plate, which is used in cervical spinal fusion surgery, following reports of post-operative fracture of a key piece of the device, notes Parker Waichman LLP. The law firm evaluates cases of defective drugs and medical devices, among other things.

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For those implanted with this device, there is the possibility of serious adverse health consequences, including blood loss and nerve injury, as well as revision surgery to replace the fractured implant, noted the FDA’s safety alert.

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, reports that the U.S. Food and Drug Administration (FDA) posted an Aug. 29 safety alert to inform the public of a class 1 recall of Stryker’s Oasys Midline Occiput Plate, which is used in cervical spinal fusion surgery, based on reports that, following surgery, the pin that connects the tulip head to the plate body can break. Such a fracture could lead to destabilization of the plate, and revision surgery may be required, the FDA warned in the safety alert.

For those implanted with this device, there is the possibility of serious adverse health consequences, including blood loss and nerve injury, as well as revision surgery to replace the fractured implant, noted the FDA’s safety alert.

Class I recalls are the most serious – involving situations “in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” the FDA reported in the safety alert. If a patient begins suffering from symptoms such as pain, weakness, or numbness, “urgent evaluation is needed,” the FDA said in the safety alert, adding that “for patients who have had a revision surgery, Stryker recommends routine post-operative care and follow-up.”

“We hope that anyone who has had cervical spinal fusion surgery involving the implanting of Stryker’s Oasys Midline Occiput Plate becomes aware of this safety alert and takes it seriously,” said Parker Waichman LLP, a national law firm that actively investigates cases involving injuries caused by defective drugs or medical devices.

In the FDA’s initial recall announcement of the product, issued on May 30, 2013, it noted that the Oasys Midline Occiput Plate is part of the Oasys System, which is used in spinal surgery to promote fusion and provide stabilization at the junction between the occipital bone and the vertebrae in the cervical and thoracic spine.

On July 22, the Australian Government’s Department of Health and Ageing issued a hazard alert regarding the Oasys Midline Occipital Plate.

Parker Waichman LLP continues to offer free legal consultations to victims of injuries caused by defective medical devices. If you or a loved one experience an injury or health problem associated with a defective medical device, please contact their office by visiting the firm's Defective Medical Devices page at yourlawyer.com. Free case evaluations are also available by calling 1-800-LAW-INFO (1-800-529-4636).

Contact:
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
1-(800) LAW-INFO
1-(800) 529-4636
http://www.yourlawyer.com

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Gary Falkowitz
Parker Waichman LLP

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