Superion Interspinous Spacer

Description of Event or Problem

It was reported that a patient implanted with a Superion Indirect Decompression System underwent an explant procedure due to ineffective pain therapy. However, the physician was unable to remove the implant as it was embedded in the patient's vertebrae too deep. There was no malfunction with the implant or instruments used in the procedure. The device remains implanted and the patient will need to be referred to a surgeon to remove the implant at a future date. The patient is reportedly doing well following the attempted explant procedure.

Additional Manufacturer Narrative

Detailed product information was not provided to BSC. We completed a good faith effort to obtain the information. Because the product is unknown at this time, we are unable to provide the complete Unique Identifier (UDI) # and other product specific information. If additional details become available, a supplemental report will be submitted.Block B3: Exact date unknown, event occurred in (b)(6) 2025.