Stryker Implant Labeled Deadly by FDA
I’ve written before about the dangers of faulty implants and the companies that continue producing them in spite of the warnings of surgeons. The latest of these treacherous products is Stryker’s OASYS Midline Occiput Plate, a spinal implant component that has been shown in many cases to fracture once it is installed in the patient, causing “serious adverse health consequences” according to the FDA.The Stryker OASIS Midline Plate is one piece of the OASYS Occipito-Cervico-Thoracic System, an implant used to aid in the fusion of the cervical spine and the occipito-cervico-thoracic junction. Reports have shown that a pin that locks into the plate body has a tendency to fracture, which can lead to nerve injury and blood loss. Once the pin is fractured a replacement surgery is often necessary.The FDA has labeled the Stryker recall Class I, its most serious recall designation and used only when “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.” Since June 20th Stryker has notified spinal transplant surgeons of the recall and advised them to conduct post-operative evaluations of patients that have received the OASIS Midline Plate.Faulty products are nothing new for Stryker, who just last year recalled both their Rejuvenate and ABG II modular-neck hip implants due to their potential for corroding inside of patients.It is an unfortunate reality that implant recipients can’t trust every approved product available to them. Personal injury lawsuits hold companies like Stryker responsible when their faulty implants cause serious damage, and act as a strong motivator to produce higher quality implants.For patients that require implants, it is important to research the product that you plan to purchase, speak with your doctor about your best options, and stay up to date with doctor visits and post-operative evaluations.Sources: Fierce Medical Devices, “Stryker recalls spinal implant, gets ‘deadly’ FDA label,” August 29 2013.Stryker, “Rejuvenate Modular / ABG II Modular-Neck Stem Voluntary Recall.”US Food and Drug Administration, “Stryker Spine – OASYS Midline Occiput Plate.”
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