Description of Event or Problem · 1
FOURS SCREWS WERE PLACED IN L5-S1 DURING MIS PROCEDURE IN A HIGH BMI PATIENT (BMI=48.9). FOLLOWING SCREWS' PLACEMENT, X RAY SCANS WERE TAKEN, DEMONSTRATING THAT THE SCREWS ON THE LEFT SIDE WERE PLACED HIGHER THAN THE RIGHT SIDE SCREWS, WHEREAS THE RIGHT SIDE SCREWS WERE PLACED ACCURATELY. THE LEFT SIDE SCREWS WERE REMOVED AND REPOSITIONED USING FLUOROSCOPY. PLACING THE SCREWS IN THE WRONG POSITION MAY CAUSE A SERIOUS INJURY ACCORDING TO THE DEFINITION OF 21CFR 803, HOWEVER, IN THIS PATIENT, THE SCREWS WERE REPOSITIONED AND NO ADVERSE EVENT WAS REPORTED. THE INVESTIGATION REVEALED THAT THE CLAMP WAS POSITIONED ON THE EDGE OF THE SPINOUS PROCESS, HOLDING A SMALL PORTION OF THE SPINOUS PROCESS WHICH MAY CONTRIBUTE FOR INSTABILITY OF THE ATTACHED CLAMP AND ITS MOVEMENT. ADDITIONALLY, IT WAS NOTED BY AUGMEDICS' REP. THAT THE Z MARKER , THAT IS FIXATED TO THE CLAMP, WAS TOUCHING THE SKIN, PRIOR TO THE SCAN. MARKER TOUCHING THE SKIN MAY RESULT IN CLAMP MOVEMENT, DUE TO THE PRESSURE APPLIED. THE USER MANUAL OF THE XVS SPECIFICALLY INDICATES THAT THE Z MARKER SHALL NOT TOUCH THE SKIN. EVEN THOUGH AUGMEDICS REP. VOICED THE CONCERNS TO THE SURGEON, PRIOR TO THE INTRA-OP SCAN, THAT THE Z MARKER SHOULD NOT TOUCH THE SKIN, THE SURGEON OPTED TO PROCEED WITH THE SCAN. AS THE SURGEON MOVED THE PLACING THE SCREWS ON THE LEFT SIDE, THE PATIENT MARKER WAS SWAPPED TO THE OPPOSITE SIDE (AS REQUIRED). THIS ACTIVITY MAY RESULT A MOVEMENT OF THE CLAMP, IF THE CLAMP IS NOT PROPERLY FIXATED TO THE SPINOUS PROCESS, WHICH IS REASONABLE TO ASSUME TO BE THE CASE,AS THE CLAMP WAS POSITIONED ON THE EDGE OF THE SPINOUS PROCESS. IF THE REGISTRATION WAS INACCURATE THEN, NONE OF THE SCREW WOULD BE PLACED ACCURATELY. ALTHOUGH DEFINITE CONCLUSION CANNOT NOT BE DRAWN FROM THE INFORMATION PROVIDED BY AUGMEDICS' PERSONNEL, WHO WAS PRESENT IN THE SURGERY, IT IS SUSPECTED THAT THE CLAMP WAS SLIGHTLY MOVED WHILE SWAPPING THE PATIENT MARKER TO THE OPPOSITE SIDE. THE EVENT SEEMS TO BE CAUSED DUE TO INCOMPLIANCE OF THE SURGEON WITH THE INSTRUCTIONS FOR USE OF THE SYSTEM AND WITH THE EXPLANATIONS PROVIDED BY AUGMEDICS' REP. WHO WAS PRESENT DURING THE PROCEDURE. AUGMEDICS REP. WILL REVIEW THE INVESTIGATION RESULTS WITH THE SURGEON AND EMPHASIZE AGAIN THE NEED TO PLACE THE CLAMP WHILE HOLDING TIGHTLY THE SPINOUS PROCESS, AND NOT JUST THE EDGE, AS WELL AS VERIFYING THE THE Z MARKER DOES NOT TOUCH THE SKIN.