PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

THIS FOLLOWUP MDR IS SUBMITTED TO SUBMIT NEW INFORMATION, INCLUDING - PRODUCT EVALUATION RESULTS OF RETURNED COMPLAINT DEVICE - THE INVESTIGATION FINDINGS CODES - INVESTIGATION CONCLUSION CODES - AND THIS MANUFACTURER'S NARRATIVE WITH THE FIRM'S ROOT CAUSE CONCLUSIONS. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE USED IN THIS CASE WAS PERFORMED AND FOUND THAT THE DEVICE MET ITS FINAL RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE AND RELEASE. A REVIEW OF COMPLAINTS FOUND NO OTHER COMPLAINTS FOR THIS LOT NUMBER. RETURNED PRODUCT EVALUATION WAS ABLE TO VERIFY THE COMPLAINT. A LARGE TEAR WAS IDENTIFIED IN THE PROXIMAL THIRD OF THE BALLOON WITH RELATIVELY CLEAN EDGES, WHICH WAS THE CAUSE OF THE LEAK. THIS KIND OF BALLOON TEAR MAY BE ATTRIBUTABLE TO THE BALLOON COMING IN CONTACT WITH AND BEING DAMAGED BY A SHARP OBJECT. FOLLOWUP INFORMATION WAS REQUESTED AND RECEIVED FROM THE SALES REP. THE LEAK OCCURRED DURING A PELVIS CASE IN WHICH TWO ILLUMINOSS IMPLANTS WERE BEING PLACED, PERFORMED BY A TEAM OF 2 USERS. TWO BALLOONS WERE PREPPED SIMULTANEOUSLY FOR THE CASE AND BOTH IMPLANTS WERE ABLE TO SUCCESSFULLY DRAW A VACUUM ON THE BACK TABLE. THE BONE CANALS WERE REAMED TO PREPARE THEM FOR THE IMPLANTS. THE BALLOONS WERE INSERTED INTO THE BONE CANALS AND AGAIN CHECKED THAT THEY ARE ABLE TO HOLD A VACUUM, AND BOTH THE BALLOONS WERE ABLE TO. WHILE ONE USER WAS FILLING THE 17X180MM IMPLANT, SIMULTANEOUSLY THE OTHER USER WAS FILLING THE 22X100MM IMPLANT. AS THE BALLOONS WERE PARTIALLY FILLED, THE SECOND USER SAW MONOMER COMING OUT OF THE BONE ENTRY HOLE. BOTH OF THE PARTIALLY FILLED BALLOONS WERE REMOVED. THEY IDENTIFIED THAT THE 22X100MM BALLOON WAS TORN. THE BONE CANAL WAS WASHED OUT THOROUGHLY, AND THE BONE CANAL WAS REAMED AGAIN. TWO NEW BALLOONS WERE THEN PLACED, AND THE PROCEDURE CONTINUED SUCCESSFULLY. THE PATIENT OUTCOME WAS GOOD. THE ILLUMINOSS SALES REP STATED THAT THE USER BELIEVED THEY KNEW WHAT HAPPENED, AND THAT IT WAS CAUSED BY USER ERROR. THIS DESCRIPTION OF EVENTS INDICATES THAT THE BALLOON DID NOT HAVE A LEAK DURING BALLOON PREP OR INITIAL PLACEMENT. THE USER REPORTED THAT THE BALLOON THAT LEAKED WAS ABLE TO HOLD A VACUUM DURING DEVICE PREPARATION, AND ALSO AFTER INSERTION INTO THE BONE CANAL BEFORE THE MONOMER INSERTION. DURING THE INFUSION OF THE BALLOON WITH MONOMER WAS WHEN THE USER OBSERVED MONOMER LEAKING OUT OF THE ENTRY HOLE. THIS MAY INDICATE THAT AS THE BALLOON WAS EXPANDING WITH MONOMER, IT PRESSED INTO A SHARP BONE FRAGMENT AND WAS TORN. AFTER THE TORN BALLOON WAS REMOVED AND CANAL CLEANED, THE CANAL WAS REAMED AGAIN. AFTER THIS SECONDARY REAMING, NEW IMPLANTS WERE PREPARED AND INSERTED, AND ABLE TO BE FULLY INFLATED AND CURED SUCCESSFULLY. CONCLUSION THE CAUSE OF THE BALLOON LEAK WAS A LARGE TEAR IN THE BALLOON. THE USER STATED THAT THEY CONCLUDED THAT USER ERROR CAUSED OR CONTRIBUTED TO THE BALLOON TEAR. A PROBABLE CAUSE FOR THIS TEAR IS THE BALLOON COMING INTO CONTACT WITH A SHARP FRAGMENT OF BONE AS IT WAS BEING INFUSED WITH MONOMER. THE TEAR OBSERVED IN THE SOFT PET WALL OF THE BALLOON DURING PRODUCT EVALUATION, PLUS THE TIMING OF THE OCCURRENCE OF THE TEAR (IN SITU), AND ALSO THE ACTION TAKEN BY THE USER TO REAM THE CANAL AGAIN PRIOR TO PLACING A SECOND BALLOON, SUPPORT THE CONCLUSION THAT THE IMPLANT WAS LIKELY INFLATING AGAINST A SHARP SURFACE OR OBJECT AND WAS TORN, CAUSING THE LEAK.

Additional Manufacturer Narrative

AT THE TIME OF THIS INITIAL MDR REPORT, THE INVESTIGATION INTO THE CAUSE OF THE EVENT IS STILL ONGOING. THE PRODUCT WAS ABLE TO BE RETURNED TO THE FIRM FOR DEVICE EVALUATION. DEVICE DECONTAMINATION WAS INITIATED ON 24 APRIL 2023. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE USED IN THIS CASE WAS PERFORMED AND FOUND THAT THE DEVICE MET ITS FINAL RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE AND RELEASE. A REVIEW OF COMPLAINTS FOUND NO OTHER COMPLAINTS FOR THIS LOT NUMBER. FOLLOWUP INFORMATION HAS BEEN REQUESTED OF THE USER. PRODUCT EVALUATION IS IN PROCESS OF BEING PERFORMED AT THIS TIME, AND A FOLLOWUP MDR WILL BE SUBMITTED WHEN FURTHER INFORMATION IS KNOWN ABOUT THIS CASE.

Description of Event or Problem

DURING A PROCEDURE TO IMPLANT 2 ILLUMINOSS IMPLANTS TO TREAT A PELVIS, AN IMPLANT TORE [SIZE 22X100MM] WHILE THEY WERE SIMULTANEOUSLY INFUSING BOTH BALLOONS WITH MONOMER. BOTH BALLOONS WERE REMOVED, AND THE TEAR WAS OBSERVED IN THE 22X100 BALLOON. THE SITE WASH WASHED OUT THOROUGHLY, THE USER REAMED UP THE CANAL A BIT MORE, THEN THEY PLACED 2 NEW BALLOONS. THE PROCEDURE WENT WELL. THE PATIENT OUTCOME WAS GOOD.