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Stryker Oasys Spine Device Recall One in a Stream of Issues for the Device Maker

Nov 5, 2013

Undergoing spinal surgery is a frightening and worrisome prospect for patients, and patients agree to these typically complex procedures believing the medical device products being used in their surgeries—and in their bodies—are safe and effective.

In the case of the Stryker Orthopedics’ Oasys Midline Occiput Plate, that was not so. The device has been recalled in the United Sates and the U.S. Food and Drug Administration (FDA) has deemed the recall a Class I, its most serious designation and one that indicates that use of the recalled device could lead to serious reactions, including death.

On May 30, 2013, Stryker issued an Urgent Medical Device Recall that requested medical facilities to look through their inventory and to stop distributing or using recalled lots of the Stryker Oasys Midline Occiput Plate. A little under one month later, on June 20, 2013, Stryker notified spinal implant surgeons and recommended that they conduct routine clinical and radiographic post-operative evaluations in their patients who had been implanted with the defective, recalled Stryker device.

The recalled Oasys Midline Occiput Plate was distributed from April 23, 2010 through February 12, 2013 and is part of the Stryker’s Oasys System. The device was created to provide cervical spine stabilization by promoting fusion; however, the agency indicated in its announcement that some patients who were implanted with the spinal device suffered from serious injuries, including blood loss and nerve injury.

The Oasys Midline Occiput Plate is implanted between the occipital bone and the vertebrae in the cervical and thoracic spine. In some cases, the device’s pin, which connects the implant’s so-called “tulip” head to the plate body, might fracture. To correct this issue, patients have had to undergo revision surgery to remove the defective device and be implanted with a different device.

It’s important to bear in mind that patients undergo these serious procedures to alleviate unremitting and unmanageable pain and related issues. When a device fails after such high hopes for an end to pain, ambulation issues, and other problems, the aftermath can be unbearable.

What’s more, the revision surgery—or surgeries—to remove the defective device is typically more complex, more painful, and more costly than original implantation surgery. During revision surgery, the surgeon is working to not only remove a defective device, but to resolve the original issue and any side effects the body suffered as a result of being implanted with a damaged device. In the case of the Oasys Midline Occiput Plate, when a fracture occurs, the plate can become destabilized. This can lead to blood loss and nervy injury with pain, numbness, and weakness. When issues such as destabilization occur with a device that has been implanted in a patient’s body, revision surgery is usually required.

Patients who have undergone cervical spinal surgery should speak to their orthopedic surgeon to determine if they have been implanted with the Stryker Oasys device. If a patient begins experiencing any symptoms indicative of device fracture, such as pain, weakness, or numbness, urgent medical evaluation is needed.

Australia’s Department of Health & Aging also issued a hazard alert for Stryker’s Oasys Midline Occipital Plate, over concerns that the spine stabilization device might fracture following surgery. The Australian hazard alert followed reports of the Oasys Midline Occipital Plate breaking in back surgery patients in the United Sates and Belgium.

By the way, the cause of the fracture defect seen the Oasys Midline Occipital Plate has not yet been identified by Stryker, which continues to investigate cases of device failure.

Meanwhile, Stryker is no stranger with issues surrounding its medical devices. For instance, the FDA limited the use of one of Stryker’s brain artery stent products following a review of clinical data.

In another recent case, Stryker was denied a preemption bid request in a lawsuit that had been filed over its bone protein product, OP-1 Putty. That case involved a woman whose lawsuit alleged that she suffered from lower backbone growth, nerve compression, significant pain, and the need for additional surgery. Preemption is legal concept that medical device makers have been using to defend themselves in liability lawsuits brought over devices that were cleared for use by the FDA but which involve allegations involving defects, injuries, and off-label use.

Stryker’s Rejuvenate and ABG II Hip Stem devices are used during hip repair surgery and are constructed with metal components that rub against each other. This defect can lead to metal ion release. Stryker recalled the Rejuvenate and the ABG II hip stem last June. This recall was followed by a second-quarter profit drop this year.

Lawsuits that name the Stryker metal-on-metal hip devices allege that the devices are defective and led to serious injuries that have necessitated revision surgery.

Stryker’s Neptune Medical Waste Management System has also been the focus of recalls—including recalls with the very serious Class I FDA designations—, an FDA warning letter, and related injury and death reports. Three Neptune System models have been implicated and there were also issues over inadequate clearance of the devices.

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