LIBERTY SI LATERAL IMPLANT SYSTEM

Description of Event or Problem

REPORTER NAME - (B)(6): THIS IS A PATIENT OF MINE WHO WAS SCHEDULED TO UNDERGO AN OUTPATIENT PERCUTANEOUS STABILIZATION OF THE SACROILIAC JOINT WITH THE SPINAL SIMPLICITY LIBERTY SYSTEM. THE PROCEDURE INVOLVED PLACEMENT OF A SMALL GUIDE PIN THROUGH THE LATERAL ILIUM AND THROUGH THE SI (SACROILIAC) JOINT AND INTO THE LATERAL SACRUM. OVER THE GUIDE PIN, A SMALL CHANNEL WAS DRILLED WITH A HAND DRILL IN ORDER TO ACCOMMODATE A SCREW. ONCE THIS HAD BEEN DONE, A SCREW WAS PLACED IN THE SPINAL SIMPLICITY INSERTING DEVICE AND PACKED WITH MATERIAL TO PROMOTE BONE GROWTH. THE SCREW WAS ADVANCED INTO THE SACRUM. AT THE TIME, THE INSERTING DEVICE HAD A KNOB THAT WOULD DEPLOY THE DISTAL END OF THE SCREW IN A FASHION THAT WOULD EXPAND THE END (A LA OPENING AN UMBRELLA), ALLOWING IT TO PROVIDE TRACTION MEDIALLY. ON THE DISTAL END OF THE SCREW, A NUT WAS ENGAGED WITH THE INSERTING DEVICE. ATTEMPTS WERE MADE TO TIGHTEN DOWN THE NUT IN ORDER TO COMPRESS THE SACROILIAC JOINT AND SECURE THE SCREW IN PLACE. HOWEVER, THE NUT DID NOT ENGAGE THE THREADED END OF THE SCREW. ATTEMPTS WERE MADE TO RE-ENGAGE THE END OF THE SCREW AS COMPRESSING THE JOINT WAS THE INTENDED OUTCOME. THE INSERTING DEVICE CONTINUED TO FAIL TO ENGAGE THE SCREW AND IMAGING DEMONSTRATED PROGRESSIVE MOVEMENT OF THE SCREW INTO THE SACRUM. DESPITE USE OF IMAGING AND MULTIPLE ATTEMPTS TO SALVAGE THE PROCEDURE, IT BECAME OBVIOUS THAT PROGRESSIVE MOVEMENT OF THE SCREW MEDIALLY PRESENTED A DANGEROUS SITUATION TO THE PATIENT (POSSIBLE SACRAL EPIDURAL ENTRY, NERVE ROOT COMPRESSION, OR BREACH OF THE ANTERIOR SACRAL WALL.) IT WAS DECIDED TO STOP FURTHER EFFORT TO COMPRESS THE JOINT, WITH THE ANTICIPATION THAT OVER TIME, MATERIAL PACKED WITHIN THE SCREW WOULD PROMOTE A BONY FUSION- OBVIATING THE NEED FOR COMPRESSION OF THE JOINT. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM WHERE IT WAS DISCOVERED SHE HAD A SACRAL RADICULOPATHY ON THE SIDE OF THE SURGERY. SHE WAS TRANSPORTED TO THE EMERGENCY ROOM AND EVALUATED BY A SURGEON. IMAGING DEMONSTRATED ADVANCEMENT OF THE SCREW THROUGH THE ANTERIOR SACRAL WALL, ABUTTING THE S1 (FIRST SACRAL) NERVE WHICH ACCOUNTED FOR HER SYMPTOMS. SHE THEN UNDERWENT SURGICAL REMOVAL OF THE SCREW AND DEFINITIVE FUSION OF THE JOINT WITH A SPINE SURGEON. SHE HAS RECOVERED WITH MINIMAL COMPLICATIONS. I HAVE SERIOUS CONCERNS SURROUNDING THE SAFETY OF THIS PRODUCT, NAMELY THE INSERTING THE DEVICE AND THE INABILITY TO SALVAGE SITUATIONS AS THE ONE I ENCOUNTERED ON THE DAY OF THIS PROCEDURE. PRIOR TO THIS SPECIFIC CASE, I HAD PREVIOUSLY PERFORMED 6 CASES WITHOUT ANY PROBLEM. I WILL NOT USE THIS PRODUCT GOING FORWARD DUE TO THE AFOREMENTIONED.