Description of Event or Problem · 1
ON (B)(6) 2010, PT UNDERWENT POSTERIOR LUMBAR REVISION DECOMPRESSION AND FUSION WITH PANGEA POLYAXIAL PEDICLE SCREW INSTRUMENTATION AT L2 TO S1 BILATERALLY, WITH SCREWS PLACED BILATERAL AT L2, L3, AND S1. PT HAD SOLID ARTHRODESIS FROM PREVIOUS SURGERY FROM L4 TO S1. FINAL TORQUE WRENCH MANEUVER PERFORMED. WRENCH REGISTERED PRESCRIBED "CLICK" TO SIGNIFY SYSTEM FINAL TIGHTENING SUCCESSFULLY PERFORMED. MFRS REP PRESENT IN ROOM TO ACKNOWLEDGE. INTRAOPERATIVE AND POSTOPERATIVE DISCHARGE X-RAYS SHOWED INSTRUMENTATION IN GOOD POSITION. PT RETURNED TO OFFICE FOR FOLLOW UP ON (B)(6) 2010, AS HE LIVES LONG DISTANCE FROM (B)(6), AND X-RAYS SHOWED TELESCOPING OF ROD OUT OF LEFT L2 SCREW, DESPITE TOP HAT STILL BEING IN PLACE. SCREW HEAD WAS ROTATED. NO CHANGE IN POSITION OF ROD IN OTHER LEFT SIDED SCREWS AT L3 AND S1. NO CHANGE IN IMPLANT ON RIGHT. FUSION WAS CONSOLIDATING AND PT WAS FEELING BETTER. PT WAS KEPT ON NO ACTIVE RANGE OF MOTION IN THERAPY. PT RETURNED TO OFFICE FOR FOLLOW UP ON (B)(6) 2010 WITH NO CHANGE ON X-RAY FROM PREVIOUS, BUT PAIN DIRECTLY OVER AREA OF LEFT L2 SCREW. PT WAS ADMITTED NEXT DAY AND DEVICE WAS EXPLANTED ON (B)(6) 2010. INTRAOPERATIVE FINDINGS WERE TELESCOPING OF ROD COMPLETELY OUT OF LEFT L2 SCREW, WITH TOP HAT STILL IN PLACE; THE SCREW STILL HAD POLYAXIAL CAPABILITY. I COULD MOVE THE ROD BETWEEN THE L3 AND S1 SCREWS, AGAIN WITH TOP HATS IN PLACE. AND ALL TOP HATS HAD SERRATIONS INDICATIVE OF THE TORQUE WRENCH HAVING BEEN APPLIED. SO, THE FINAL TIGHTENING MECHANISM HAD FAILED. I COULD MOVE THE RIGHT ROD BETWEEN EACH OF THE RIGHT L2, L3 AND S1 SCREWS, EVEN WITH THE TOP HATS IN PLACE AND HAVING THE SERRATIONS OF THE TORQUE WRENCH HAVING BEEN APPLIED. THE PT WAS REINSTRUMENTED WITH ANOTHER COMPANY'S PEDICLE SCREW SYSTEM. I THINK THAT THE TORQUE WRENCH TIGHTENED JUST ENOUGH TO HOLD THE COMPONENTS TOGETHER FOR TWO TO THREE MONTHS UNTIL THE CYCLICAL LOADING OF BODY MOTIONS AND FORCES CAUSED THE CONNECTION TO FAIL. ALTERNATIVELY, THERE IS A GROSS DEFECT IN THE OVERALL FINAL TIGHTENING OF THE SCREW, ROD AND TOP HAT. NAME: PANGEA FINAL TORQUE WRENCH. STRENGTH: RETURNED TO MFR 9/30/2010 BY HOSPITAL. MFR: SYNTHES USA; NAME: PANGEA SCREW-ROD-TOP HAT CONNECTION MECHANISM. STRENGTH: I HAVE THE IMPLANTS. MFR: SYNTHES USA. DIAGNOSIS OR REASON FOR USE: LUMBAR DISC HERNIATION WITH SPONDYLOSIS; RECURRENT LUMBAR SPINAL STENOSIS WITH RETROLISTHESIS. SUSPECT DEFECT IS IN THE CALIBRATION OF THE FINAL TORQUE WRENCH OR IN THE SCREW-ROD-TOP HAT CONNECTION THAT FAILS CYCLICALLY OVER TIME WITH BODY MOTION AND FORCES.