There is always potential risk in having surgery or getting a medical device implanted. Usually these risks are rare. You should refer to the Coflex® Patient Labeling for a list of all potential risks and hazards that were observed during the clinical study. For patients receiving the Coflex® device, the biggest risk is continued pain. Other risks include wound healing problems (such as infection or drainage), brief numbness or tingling in your arms or legs, and spinous process fractures. Some patients had illnesses or diseases not related to their surgery, like problems with their skin, problems breathing, problems with their heart, and other muscle or bone pain or soreness. In the clinical trial, similar problems were experienced with patients who had fusion. The Coflex® device may not help relieve pain in some patients, and you may need another surgery to remove the device. It is hard to predict who will not benefit from this surgery. Although uncommon, the device could be removed if necessary.