FDA Labels Stryker Spinal Implant Deadly

deadly Stryker spinal implantThe U.S. Food and Drug Administration (FDA) has recently assigned its most serious label to Stryker’s spinal implant, warning consumers that the use of the device could potentially cause serious side effects, devastating injury or even death. The Stryker spinal implant in question is the Oasys Occipito-Cervico-Thoracic System, an implant intended to stabilize and support the connection between the vertebrae and the occipital bone in the spine.

About the Current Deadly Stryker Spinal Implant Recalls

The manufacturer acknowledges that they have received numerous reports that a pin in the Stryker spinal implant that connects the plate body to the tulip head may fracture and potentially cause nerve injury, pain, numbness, weakness, blood loss and the need for revision surgery. As a result, the FDA placed a Class I designation on the recall, a label reserved only for possibly deadly malfunctions. Patients who have received a Stryker Oasys spine implant and experienced any of these effects are urged to seek medical attention immediately to avoid the risk that these symptoms may become life-threatening or fatal.

The recall was initiated in May 2013, and the company warned patients and physicians to stop using the affected lots; the medical community was asked to ship any remaining devices back to the company. The recalled products were manufactured by Stryker Spine of Allendale, New Jersey and distributed to medical communities between April 23, 2010 and February 12, 2013.

In June 2013, Stryker also released a warning to surgeons and healthcare providers, urging them to conduct routine post-op evaluations on patients who were implanted with the deadly Stryker spinal implant. Physicians were instructed to look for symptoms or indications that the patient may need a revision procedure and closely monitor existing patients for signs of complications during implantation.

In August 2013, Stryker released a statement in which the company explained the timeline of the recall yet they refuse to comment on how much the recall should cost them or how many implants are affected. The FDA has stated that any patient who begins to experience symptoms of the defect such as pain, numbness or weakness should seek an immediate evaluation from their healthcare provider. For patients who have already undergone revision surgery, the FDA advises follow-ups or routine post-operative care to ensure that the implant will not cause future harm.

Lawsuits Against Stryker

Stryker is no stranger to lawsuits; last year, the company’s ABG II and Rejuvenate hip implants were the subjects of lawsuits across the country. Experts estimate that Stryker was forced to pay over $400 million for revision surgeries and legal fees. Stryker recalled these two systems, an act that came three months after the company issued a notice to hospital risk managers and surgeons across the country, acknowledging that there were potential health hazards such as corrosion and fretting. Plaintiffs allege that the metal-on-metal components of these devices would rub together, releasing metallic shards into the blood stream, bones and tissues.

Considering Filing a Claim for the Deadly Stryker Spinal Implant?

Have you or someone you love received a recalled hip implant or the deadly Stryker spinal implant and are curious about your rights? Are you suffering from weakness, numbness, loss of blood, nerve injury or unexplainable pain? The affiliated attorneys at the Attorney Group can work with you to evaluate your case and determine if you have a claim against the manufacturer. Depending on the circumstances surrounding your situation, you may be entitled to seek compensation for pain and suffering, medical bills, revision surgeries, lost wages or any injuries you may have sustained while you were fitted with these devices. Attorney Group can provide this information all at no cost to you, so contact us today.