PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

CONTEXT: THE DEVICE IN QUESTION IS AN INTRAMEDULLARY BALLOON CATHETER (IBC) THAT IS PART OF THE ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM (PBSS). IT IS A FORMED-IN-PLACE INTRAMEDULLARY IMPLANT USED TO STABILIZE BONE FRACTURES IN MUCH THE SAME WAY AS AN INTRAMEDULLARY NAIL (IMN) DOES. DETAILS OF THE IBC ARE AS FOLLOWS: THE IBC CONSISTS OF A BALLOON ATTACHED TO A CATHETER AND Y-BODY ASSEMBLY THAT ALLOWS THE USER TO INFUSE MONOMER MATERIAL INTO THE BALLOON TO FILL IT ONCE IT IS IN THE INTRAMEDULLARY CANAL AND PLACED ACROSS THE FRACTURE SITE. THE CATHETER AND Y-BODY ALSO ALLOW ACCESS FOR THE LIGHT FIBER INTO THE BALLOON WHICH PROVIDES THE LIGHT NECESSARY TO HARDEN THE MONOMER INTO A POLYMER. THE BALLOON, ONCE HARDENED, IS NOW ABLE TO STABILIZE THE FRACTURE DURING THE HEALING PROCESS. SPECIFIC DIFFERENCES BETWEEN THE IBC AND IMN IS THAT THE IBC IS A FORMED IN PLACE IMPLANT. THE NAIL IS NOT. THE IBC, UNLIKE THE IMN, MUST HAVE CORTICAL CONTACT ALONG ITS LENGTH . BECAUSE OF THIS CORTICAL CONTACT, CROSS-LOCKING SCREWS ARE NOT REQUIRED, WHICH IS ALSO NOT THE SAME AS AN IMN AS AN IMN REQUIRES THESE SCREWS FOR STABILITY. FOR HUMERAL FRACTURE TREATMENTS, IT IS RECOMMENDED THAT THE DIAMETER OF THE CREATED IMPLANT BE A MINIMUM OF 13MM IN ORDER TO PROVIDE OPTIMAL STRENGTH IF USED ON ITS OWN. THIS IS STATED IN THE SURGICAL TECHNIQUE GUIDE (P/N 900510), IT STATES THAT IF THE 13MM DIAMETER IS NOT ACHIEVED IT IS RECOMMENDED TO SUPPLEMENT THE BALLOON IMPLANT WITH AN FDA CLEARED PLATE AND SCREWS. INVESTIGATION RESULTS: THE EVIDENCE USED IN DETERMINING THE POSSIBLE CAUSE(S) FOR THE BROKEN DEVICE, INCLUDED A REVIEW OF THE COMPLAINT DETAILS PROVIDED BY THE ILLUMINOSS ASD (AREA SALES DIRECTOR) WHO RECEIVED THE COMPLAINT FROM THE ATTENDING SURGEON. ALSO USED DURING THE INVESTIGATION WERE RADIOGRAPHS, WHICH WERE PROVIDED ALONG WITH THE COMPLAINT DETAILS. FROM THIS INFORMATION, THE FOLLOWING ASSESSMENTS WERE MADE: IT WAS OBSERVED UPON REVIEW OF THE RADIOGRAPHS, THAT THE AREA AROUND THE FRACTURE SHOWED LITTLE CALLUS GROWTH INDICATING THE LACK OF HEALING THAT WAS MENTIONED IN THE COMPLAINT DETAILS. BECAUSE OF THE PATIENT'S CONDITION AT THE TIME OF THE IMPLANTATION, WHICH WAS METASTATIC BONE DISEASE, A LONGER HEALING PERIOD WOULD BE ANTICIPATED. THE REPORTED IMPLANT BREAK WAS REPORTED BETWEEN 591 AND 621 DAYS AFTER IMPLANTATION. WITHOUT ANY FRACTURE HEALING, THE IMPLANT MUST TAKE ON ALL OF THE LOAD AS OPPOSED TO SHARING IT WITH THE HEALING BONE. GIVEN THIS INFORMATION AND THE LENGTH OF TIME THAT THE DEVICE HAD BEEN IMPLANTED WITH NO HEALING OF THE FRACTURE SITE, THE CONTRIBUTING CAUSE OF THE BREAK APPEARS TO BE THE RESULT OF THE CHRONIC NON-UNION LEADING TO A FATIGUE FAILURE OF THE IMPLANT.

Description of Event or Problem

DR. (B)(6), AN ILLUMINOSS NON-USER, REVISED AN ILLUMINOSS SYSTEM ORIGINALLY IMPLANTED BY (B)(6) ON (B)(6) 2018. FOLLOWING THE IMPLANT OF AN ANTEGRADE 22/13X220 AND A RETROGRADE 17X260 WITH POOR REDUCTION, THE PATIENT DID NOT HEAL WHICH CREATED A CHRONIC NON-UNION. ON, OR ABOUT (B)(6) 2020, THE PATIENT SUSTAINED A FRACTURE OF THE ILLUMINOSS SYSTEM. ON (B)(6) 2020, (B)(6) REMOVED THE PROXIMAL PORTION OF THE ILLUMINOSS SYSTEM WITH EASE, LEFT THE DISTAL PORTION OF THE ILLUMINOSS IN TACT AND THEN PROCEEDED TO INSTALL A ZIMMER PROXIMAL HUMERUS PLATE OVER THE HUMERAL HEAD AND SHAFT. FOLLOWING THE PLATE, HE PACKED ANY REMAINING DEFECT WITH BONE CHIPS AND THEN CLOSED THE SITE. PATIENT WAS STABLE PRE AND POST SURGERY.