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SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators News

Have you suffered from back pain, injury, or infection? If you have, you may have undergone spinal fusion surgery.

This is a procedure that helps to keep the spine stable by connecting two or more vertebrae in the lower back. The purpose is similar to that of taping two fingers together to stabilize a broken bone. The surgery is achieved either by grafting a bone to the spine to create a bridge between two or more vertebrae or by using a metal implant to hold vertebrae together until new bone tissue develops between them . If you’ve undergone spinal fusion surgery, your doctor may have used one of Zimmer Biomet’s SpF PLUS-Mini or SpF XL IIb Implantable Spinal Fusion Stimulators to aid in your recovery process.

Spinal fusion simulator are supplemental devices that attempt to assist and heighten the body’s natural bone healing process by emitting low level electrical signals to stimulate bone growth.

Are SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators Safe?   

According to Zimmer Biomet’s website, over 100,000 of their spinal fusion simulators have been implanted in patients who have undergone spinal fusion. Over the course of their clinical history, the spinal fusion simulators have proven to be effective as a supplemental option to speed the recovery process. Though Zimmer Biomet warns against using their spinal fusion simulators in special cases—such as if the device is at risk of coming into contact with a metallic implant—the devices have proven to be typically safe.

Despite the typical safety of these devises, a recent FDA recall warns users that a recent batch of spinal fusion simulators has been found faulty. You should be especially aware of this recall if you had a spinal fusion simulator implanted between March 28, 2017 and April 6, 2017. Devices manufactured between October 11, 2016 and January 18, 2017 were found to contain atypically high levels of potentially dangerous chemicals. These devices may not be safe, and if you believe you or a loved one may have one of these devices implanted, you should contact your doctor immediately and consider taking legal action.

SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Simulators Side Effects 

Possible side effects caused by the affected devices include chronic infection, additional medical procedures (which could lead to extended hospitalization), paralysis, or even death. These side effects could be triggered by chemicals contained in the spinal fusion simulators that are toxic to body tissue and organs.

Beginning on April 20, 2017, Zimmer Biomet’s team has been contacting appropriate medical personnel to alert customers of the potential danger. They are working to remove affected devices from medical facilities and recommend normal clinical monitoring for patients with an affected device already implanted.

If you or a loved one experience negative side-effects as a result of an implanted SpF PLUS-Mini or SpF XL IIb Implantable Spinal Fusion Stimulator, you should contact a lawyer. You may need to file a lawsuit. Additionally, the FDA encourages you to file a report through the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

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