All spinal surgery carries some risk including, but not limited to the risks of infection, bruising and blood clots, adverse reaction to anesthesia, pain or discomfort at the operative site, pneumonia, stroke, myocardial infarction, bleeding, pain and, rarely, paralysis or death.
Complications that are considered more relevant to implantation of the X-STOP device (as opposed to laminectomy or laminectomy plus fusion) are:
- Failure of the device/procedure to relieve symptoms and/or improve the patient’s ability to function in activities of daily living
- The need for additional surgery (e.g. a laminectomy) to relieve the patient’s leg pain and symptoms. This surgery could include removal of the implant
- The risk of the implant becoming dislodged or moving out of place
- The potential for the implant to not be positioned correctly, which could increase the patient’s pain
- A fracture of the spinous process while inserting the X-STOP or even after the surgery
- A foreign body reaction (e.g. an allergic reaction) to the implant (titanium and/or PEEK)
- A mechanical failure of the implant, which has two parts
Patients contemplating use of the X-STOP are advised to ask their surgeon about risks and about the complications the surgeon has seen in using the device in his or her practice, including the risk that the surgery may not alleviate the patient’s leg pain.
Adverse events involving medical devices, including some related to the X-STOP must be reported by law to the Food and Drug Administration and are documented on the FDA website.