PHOTODYNAMIC BONE STABILIZATION SYSTEM

Description of Event or Problem

A REGISTRY PATIENT WAS ASSESSED ON (B)(6) 2024 FOR A TRAUMATIC FALL ON (B)(6) 2024. THE PATIENT SUSTAINED 2 FRACTURES IN THE PELVIS. ON (B)(6) 2024 AN ILLUMINOSS WAS IMPLANTED TO TREAT ONE FRACTURE IN THE PELVIS WITH NO OTHER DEVICES USED. ON (B)(6) 2024 THE ADVERSE EVENT OF PAIN IN THE ILLUMINOSS CURED BONE (MILD AND POSSIBLY RELATED TO THE ILLUMINOSS DEVICE) OCCURRED, WITH A VAS SCORE OF 3 AND X-RAY WITHOUT FINDINGS.

Additional Manufacturer Narrative

ROOT CAUSE INVESTIGATION. MEDICAL OVERSIGHT REVIEW: A MEDICAL OVERSIGHT REVIEW MEETING WAS HELD WHERE THE INFORMATION IN THIS COMPLAINT WAS REVIEWED. IT WAS NOTED THAT THERE WAS NOT A LOT OF INFORMATION AVAILABLE ABOUT THIS COMPLAINT, AND THE WEIGHT BEARING STATUS OF THE PATIENT IS UNKNOWN AND NO X-RAYS ARE AVAILABLE. THE MEDICAL REVIEWER NOTED THAT A PATIENT OF THIS AGE (85) MAY HAVE RESIDUAL PAIN AFTER THE PROCEDURE, AND THERE ARE TOO MANY UNKNOWN TO KNOW IF THE PAIN ONE MONTH POST OP IS RELATED TO THE ILLUMINOSS DEVICE. DHR REVIEW: THE DHR OF LOT 431411 WAS REVIEWED AND FOUND TO BE IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. RETURNED PRODUCT EVALUATION: NOT AVAILABLE AS TO THE BEST OF COMPANY'S KNOWLEDGE THE DEVICE REMAINS IMPLANTED. IFU REVIEW: THE IFU 900535_E STATES THAT RISKS INCLUDE "PAIN AND/OR LOSS OF FUNCTION", SO THE RISK OF PAIN IS CAPTURED IN THE LABELING. PELVIS IS NOT CURRENTLY AN INDICATED USE IN GERMANY FOR THE PRODUCT USED (SL-0900160), SO THIS COMPLAINT WAS FOR OFF LABEL USE. HOWEVER, IT IS NOTED THAT PELVIS IS INCLUDED AS AN INDICATION IN THE MDR APPLICATION IN GERMANY, WHICH IS UNDERWAY, AND IS AN INDICATED USE IN THE US FOR THE SAME PRODUCT, SO THE OFF LABEL USE IS NOT THE CAUSE OF THE COMPLAINT. POTENTIAL FOR USER ERROR: IT IS UNKNOWN IF USER ERROR CONTRIBUTED TO THE COMPLAINT. X-RAYS WERE NOT PROVIDED SO IT IS UNKNOWN IF THE IMPLANT DEVICE WAS PROPERLY POSITIONED OR IMPLANTED IN THE PATIENT. FOLLOW UP: THE SITE WAS CONTACTED AND X-RAYS FOR THIS PATIENT WERE REQUESTED TO SUPPORT THE COMPLAINT INVESTIGATION. THE SITE CONFIRMED THAT THE INFORMATION PROVIDED IN THE REGISTRY IS WHAT WILL BE PROVIDED. THE USER WAS ALSO CONTACTED WITH A REQUEST FOR MORE INFORMATION AND NO ADDITIONAL INFORMATION WAS PROVIDED. CONCLUSION: WITH THE INFORMATION AVAILABLE IN THIS COMPLAINT, THE ROOT CAUSE OF THE PAIN IN THE ILLUMINOSS TREATED BONE ONE MONTH POST OP IS UNKNOWN. THE MEDICAL OVERSIGHT REVIEW DETERMINED THAT THERE IS NOT ENOUGH INFORMATION AVAILABLE TO KNOW IF THIS REPORTED PAIN IS RELATED TO THE ILLUMINOSS DEVICE.

Description of Event or Problem

REGISTRY SUBJECT (B)(6), ADVERSE EVENT: PAIN. PAIN IN ILLUMINOSS CURED BONE, VAS SCORE 3, X-RAYS WITHOUT FINDINGS.

Additional Manufacturer Narrative

PENDING ADDTIONAL INFORMATION AND INVESTIGATION.