LIBERTY SI

Description of Event or Problem

SPINAL SIMPLICITY RECEIVED A MEDWATCH REPORT (MW5188936) STATING THAT A LIBERTY SI IMPLANT WAS IMPLANTED ON (B)(6) 2026. DURING THE SURGICAL PROCEDURE IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO TIGHTEN THE NUT OVER THE SCREW CREATING A COMPRESSION OF THE JOINT. AN ATTEMPT TO TIGHTEN THE NUT CAUSE THE SCREW TO MOVE FORWARD. THEREFORE, IT WAS DECIDED TO KEEP THE IMPLANT IN PLACE AND ALLOW FOR BONY-FUSION TO OCCUR. AFTER BEING TAKEN TO THE RECOVERY ROOM IT WAS IDENTIFIED THAT THE PATIENT HAD SACRAL RADICULOPATHY ON THE SIDE OF SURGERY. SHE WAS TRANSPORTED TO THE HOSPITAL AND IT WAS REPORTED THAT THE IMPLANT HAD ADVANCED THROUGH THE ANTERIOR SACRAL WALL, ABUTTING THE S1 (FIRST SACRAL) NERVE WHICH MAY HAVE CAUSED HER SYMPTOMS. THE PATIENT UNDERWENT SURGERY TO REMOVED THE IMPLANT ON (B)(6) 2026.

Additional Manufacturer Narrative

THE LIBERTY SI IMPLANT AND THE INSERTION INSTRUMENT WERE REQUESTED TO BE RETURNED TO THE MANUFACTURER. THE LIBERTY SI IMPLANT WAS NOT RETURNED FOR EVALUATION. AN INSERTION INSTRUMENT WAS RETURNED FOR EVALUATION; IT IS UNCLEAR IF THE RETURNED INSERTION INSTRUMENT WAS THE ONE USED IN THIS SURGICAL PROCEDURE. THE SPANNER SHAFT OF THE RETURNED INSERTION INSTRUMENT SHOWS MULTIPLE FRACTURES, WHICH HAD NOT BEEN PREVIOUSLY OBSERVED. INFORMATION PROVIDED SUGGESTS THAT THE PATIENT MAY HAVE HAD A PREEXISTING ALLOGRAFT IMPLANT IN THE SI JOINT. AN ALLOGRAFT IMPLANT CAN BE PERCEIVED AS DENSE BONE. THE IMPLANTING PHYSICIAN MAY HAVE INTERPRETED AS BEING ABLE TO DRILL THROUGH THE ALLOGRAFT WITH THE INSERTION INSTRUMENT AND IMPLANT. PER THE LIBERTY SI SURGICAL TECHNIQUE GUIDE (STG), IF DENSE BONE IS OBSERVED, THE STG DIRECTS THE USER TO USE THE DRILLING INSTRUMENT TO DRILL FULLY THROUGH THE ILIUM AND BREACH THE SACRAL WALL, RATHER THAN USING THE INSERTION INSTRUMENT AND IMPLANT TO BREACH THE WALL. IF DENSE BONE IS OBSERVED WHILE ATTEMPTING TO PLACE THE IMPLANT, THE STG GUIDES THE USER TO BACK OUT THE INSERTER AND REDRILL, UNTIL THE LATERAL SACRAL CORTICAL WALL HAS BEEN BREACHED. IF THIS IS NOT FOLLOWED, AND THE INSERTION INSTRUMENT WITH THE IMPLANT IS USED TO CONTINUE TO DRILL, IT MAY CAUSE THE INSERTION INSTRUMENT TO MALFUNCTION AND POSE DIFFICULTLY PLACING THE IMPLANT.