Description of Event or Problem · 1
THE SET SCREW (P/N PS5.5-4001, LOT#10672-01) IS AN IMPLANTABLE COMPONENT UTILIZED IN CONJUNCTION WITH THE PEDICLE SCREW AND ROD. IT IS A PART WITHIN THE AGOGE PEDICLE SCREW SYSTEM. THIS EVENT INVOLVED A SURGEON PERFORMING A 10 LEVEL SURGERY. DURING THE CASE, TEN (10) SET SCREWS WOULD NOT PROPERLY THREAD AND TIGHTEN INTO THE PEDICLE SCREW CUPS. THE SET SCREWS IN QUESTION WERE INSERTED INTO THE PEDICLE SCREWS, BUT THE SURGEON WAS UNABLE TO TIGHTEN THEM. THESE SET SCREWS WERE EXPLANTED, AND NEW SET SCREWS SUCCESSFULLY IMPLANTED. DUE TO THE INCIDENT DESCRIBED, THE SURGERY WAS PROLONGED TEN (10) MINS. ROYAL OAK MEDICAL DEVICES REVIEWED THE DEVICE HISTORY RECORD FOR P/N PS.5-4001, LOT 10672-01 AND DETERMINED THAT THERE WAS NO EVIDENCE WITHIN THE FILE TO INDICATE THAT THE PART WOULD CAUSE THE DEVICE TO FAIL. ROYAL OAK MEDICAL DEVICES ALSO REVIEWED THE DHR'S FOR THE FOLLOWING PEDICLE SCREWS WHICH WERE IMPLANTED DURING THE SURGERY: PS5.5-4.5-45 (LOT 10680-04), PS5.5-5.5-45 (LOT 10703-09), PS5.5-5.5-50 (LOT 10681-05), PS5.5-6.5-45 (LOT 10703-14), PS5.5-6.5-50 (LOT 10703-15), PS5.5-6.5-55 (LOT 10682-06), PS5.5-7.5-45 (LOT 10703-20) AND PS5.5-7.5-55 (LOT 10683-06). THERE WAS NO EVIDENCE NOTED IN THE DHR'S THAT SUGGESTED THE PEDICLE SCREWS WOULD NOT MEET THE DESIGN SPECIFICATIONS. NONE OF THE PEDICLE SCREWS WERE EXPLANTED. BASED ON THE INABILITY TO EVALUATE THE PARTS, LIMITED CONCLUSIONS MAY BE DRAWN REGARDING THE CAUSE OF THIS FAILURE. A PRELIMINARY ASSESSMENT INDICATES THAT THE FAILURE MAY HAVE BEEN CAUSED BY USER ERROR IN THE PLACEMENT OF THE SPINAL RODS. THE RODS MUST BE PROPERLY SEATED INTO THE PEDICLE SCREW CUP BEFORE INSTALLING AND TIGHTENING THE SET SCREW. IN THIS SURGERY, IT IS BELIEVED THAT THE RODS MAY NOT HAVE BEEN PROPERLY SEATED INTO THE PEDICLE SCREW CUP PRIOR TO INSTALLING THE SET SCREWS.