PHOTODYNAMIC BONE STABILIZATION SYSTEM

Description of Event or Problem

AN ADVERSE EVENT WAS ENTERED INTO THE CLINICAL REGISTRY ON AUGUST 14, 2024, FOR A RETROSPECTIVE PATIENT. REGISTRY SUBJECT (B)(6) UNDERWENT PERCUTANEOUS FIXATION OF HER RIGHT SIDED ACETABULAR FRACTURE ON (B)(6) 2022. SHE HAD SYMPTOMATIC HARDWARE IN THE GROIN DUE TO A LONG ILLUMINOSS NAIL USED. SURGICAL REMOVAL OF THE SYMPTOMATIC ASPECT OF THE IMPLANT WAS INDICATED TO DECREASE HER PAIN AND TENDERNESS AND INCREASE HER AMBULATION. (THE IMPLANT REMOVAL WAS PARTIAL - OSTEOTOMY OF THE LONG PART OF THE IMPLANT). AE RESOLVED AFTER PARTIAL REMOVAL.

Additional Manufacturer Narrative

ROOT CAUSE INVESTIGATION: A MEDICAL OVERSIGHT REVIEW MEETING WAS HELD WHERE THE X-RAYS AND CASE INFORMATION WAS REVIEWED. IT WAS OBSERVED ON THE INDEX PROCEDURE AND 75 DAY FOLLOW UP X-RAYS THERE APPEARS TO BE POTENTIALLY TWO AREAS OF THE ILLUMINOSS IMPLANTS WHICH WERE EXTRAOSSEOUS . IT APPEARS THAT THE EXTRAOSSEOUS PORTION OF THE IMPLANT VISIBLE IN THE INDEX PROCEDURE X-RAY OVER THE PROXIMAL FEMUR WAS PARTIALLY REMOVED DURING THE REVISION SURGERY AS THAT IMPLANT APPEARS SHORTER IN THE 75 DAY FOLLOW UP X-RAY. THE EXTRAOSSEOUS PORTION OF THE IMPLANT STICKING OUT THE ILIAC OBLIQUE ON THE 75 DAY FOLLOW UP X-RAY APPEARS TO HAVE NOT BEEN REMOVED DURING THE REVISION SURGERY AND REMAINS PARTIALLY OUTSIDE THE BONE. HOWEVER, THE MEDICAL REVIEWER NOTED THAT DUE TO THE DIFFERENT VIEWS OF THE PELVIS ON THE X-RAYS PROVIDED FROM THE INDEX PROCEDURE AND FOLLOW UPS, IT IS DIFFICULT TO DETERMINE EXACTLY WHAT PORTIONS OF THE IMPLANTS WERE EXTRAOSSEOUS, AND WHAT PORTIONS OF THE IMPLANTS WERE REMOVED DURING THE REVISION PROCEDURE. THE MEDICAL REVIEWER ALSO NOTED THAT THE FRACTURE MAY OR MAY NOT HAVE HEALED, THE PATIENT LIKELY HAS SOME INCONGRUITY AND POST TRAUMATIC ARTHRITIC PAIN WHICH COULD ALSO BE CONTRIBUTING TO THE PAIN THE PATIENT IS EXPERIENCING. THE MEDICAL REVIEWER STATED THAT IT APPEARS THE CAUSE OF THE PORTIONS OF THE IMPLANT WHICH ARE EXTRAOSSEOUS ARE EITHER DUE TO THE POSITIONING FAILURE DURING THE IMPLANT DELIVERY IN WHICH IT WAS NOT PROPERLY PLACED COMPLETELY IN THE BONE, OR A PROBLEM WITH THE IMPLANT SIZE SELECTION (IMPLANT BEING TOO LONG). DHR REVIEW: THE DHR OF THE THREE LOTS INVOLVED (410899, 420406 AND 420430) WERE REVIEWED AND FOUND TO BE IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. THERE IS NO INDICATION THAT THE MANUFACTURE OF THE DEVICE CONTRIBUTED TO THIS COMPLAINT EVENT. RETURNED PRODUCT EVALUATION: THIS COMPLAINT WAS RETROSPECTIVE ENTERED INTO THE CLINICAL REGISTRY FROM 2022, SO THE PARTIAL IMPLANT REMOVED FROM THE PATIENT DURING THE REVISION HAS SINCE BEEN DISCARDED AND NOT AVAILABLE FOR RETURN AND EVALUATION. IFU REVIEW IFU 900356_X STATES "CORRECT SELECTION OF THE IMPLANT DIAMETER AND LENGTH IS EXTREMELY IMPORTANT, AND SHOULD BE DETERMINED BEFORE IMPLANTATION: ENSURE THE IMPLANT IS LONG ENOUGH TO SPAN THE FRACTURE, AND IS NOT LONGER THAN THE CANAL." THE IFU ALSO STATES THE RISKS INCLUDE PAIN AND/OR LOSS OF FUNCTION, REVISION AND INABILITY TO PROPERLY DEPLOY OR REMOVE THE DEVICE. THE STG FOR PELVIS 900598_A ALSO STATES "THE DETERMINATION OF AN IMPLANT LENGTH AND DIAMETER MAY BE PERFORMED PRE-OPERATIVELY OR AFTER THE START OF THE PROCEDURE. IN DETERMINING THE APPROPRIATE ILLUMINOSS IMPLANT LENGTH TO SELECT THE IMPLANT SHOULD SPAN THE ENTIRE LENGTH OF THE FRACTURE SITE IN ORDER TO STABILIZE IT, PLUS A SUFFICIENT LENGTH WITHIN BONE THAT HAS NOT BEEN COMPROMISED[?]. THE USE OF FLUOROSCOPY IS MANDATORY DURING IMPLANTATION OF THE ILLUMINOSS SYSTEM. IT IS INCUMBENT UPON THE SURGEON THAT THEY USE FLUOROSCOPY AS THEY WOULD WITH THE USE OF STANDARD INTRAMEDULLARY SYSTEMS AND THAT THEY TAKE FLUOROSCOPY IMAGES THROUGHOUT THE PROCEDURE AS NECESSARY TO ASCERTAIN CORRECT INSTRUMENT POSITIONING AS WELL AS CORRECT FRACTURE REDUCTION[?] USE OF FLUOROSCOPY TO CONFIRM THE PROPER POSITION OF THE IMPLANT (ANTERIOR, POSTERIOR, AND INLET/OUTLET) SPANNING THE FRACTURE SITE AND ENSURE THAT THE FRACTURE REMAINS SUFFICIENTLY REDUCED OR ADJUSTMENTS TO THE POSITION OF THE BALLOON MAY BE REQUIRED." THE LABELING INCLUDES THE INSTRUCTIONS TO SELECT THE CORRECT IMPLANT LENGTH SUCH THAT THE IMPLANT IS NOT LONGER THAN THE CANAL, INSTRUCTIONS TO USE FLUOROSCOPY TO ENSURE PROPER POSITIONING OF THE IMPLANT, AND THAT RISKS INCLUDE PAIN AND/OR LOSS OF FUNCTION, REVISION AND INABILITY TO PROPERLY DEPLOY OR REMOVE THE DEVICE. THEREFORE, THE RISKS ARE INCLUDED IN THE LABELING AND INSTRUCTIONS ON HOW TO PROPERLY SELECT AN IMPLANT SIZE AND PROPERLY DEPLOY THE IMPLANT INTRAOSSEOUS. POTENTIAL FOR USER ERROR THE POTENTIAL FOR USER ERROR AS THE CAUSE OF COMPLAINT INCLUDES INCORRECT SELECTION OF IMPLANT SIZE (BALLOON CATHETER LENGTH SELECTION TOO LONG) OR IMPROPER PLACEMENT OF BALLOON DURING PROCEDURE. BOTH OF THESE USER ERRORS COULD RESULT IN A PORTION OF THE IMPLANT BEING EXTRAOSSEOUS. CONCLUSION: THE CAUSE OF THE EXTRAOSSEOUS PORTION OF THE ILLUMINOSS IMPLANT CAUSING PAIN IS EITHER DUE TO INCORRECT SELECTION OF IMPLANT SIZE BY THE USER (TOO LONG) OR IMPROPER PLACEMENT OF THE BALLOON DURING THE PROCEDURE, LEAVING A PORTION OF THE IMPLANT EXTRAOSSEOUS. OTHER POTENTIAL CAUSES OF THE PATIENT PAIN OUTSIDE THE EXTRAOSSEOUS PORTION OF THE IMPLANT COULD BE THAT THE FRACTURE MAY OR MAY NOT HAVE HEALED, AND THE PATIENT LIKELY HAS SOME INCONGRUITY AND POST TRAUMATIC ARTHRITIC PAIN. THE ROOT CAUSE WAS NOT ABLE TO BE NARROWED DOWN TO ONE SINGULAR FAILURE MODE AND CAUSE WITH THE AVAILABLE INFORMATION.