PHOTODYNAMIC BONE STABILIZATION SYSTEM

Additional Manufacturer Narrative

THE CAUSE OF AN EXPIRED IMPLANT KIT BEING USED IN A PROCEDURE IS DUE TO AN EXPIRED IMPLANT KIT BEING IN THE DISTRIBUTOR'S STOCK AVAILABLE FOR USE, AND THAT THE PAST EXPIRATION DATE OF THE PRODUCT WAS NOT IDENTIFIED PRIOR TO USE BY THE USER AND OR STAFF. THE REP STATED THAT BECAUSE THE SURGEON SWITCHED BALLOON SIZES AND REMOVED A SMALLER BALLOON AND REQUESTED A LONGER BALLOON IT RESULTED IN QUICK PREPARATION OF THE IMPLANT AND CAUSED THE PAST EXPIRATION DATE TO BE OVERLOOKED BY THE DISTRIBUTOR AND OR STAFF PRIOR TO IMPLANT USE. A REVIEW OF THE DHR OF THE IMPLANT IDENTIFIED THAT THE COMPONENTS WHICH WERE EXPIRED WERE THE STERILE SYRINGES (QTY 2) WHICH HAD AN EXPIRATION DATE OF 28 FEB 2025. THE MONOMER, IMPLANT AND VENTED TRANSFER SPIKE COMPONENTS ON THE KIT HAD NOT YET EXPIRED. ADDITIONAL INFORMATION WAS RECEIVED THAT ONLY ONE SYRINGE WAS USED IN THE PROCEDURE.

Description of Event or Problem

AN IMPLANT KIT (LOT 410911) WITH A SYSTEM EXPIRATION DATE OF 28 FEB 2025 WAS IMPLANTED ON (B)(6) 2025. THE IMPLANT SIZE ORIGINALLY SELECTED FOR THE CASE WAS AN 11X160MM, WHICH WAS OPENED AND INSERTED, THEN REMOVED BECAUSE THE SURGEON WANTED A LONGER BALLOON. THE USER THEN REQUESTED AN 11X220MM BALLOON WHICH WAS OPENED AND INSERTED. AFTER THE IMPLANT WAS USED THE REP NOTICED THE IMPLANT EXPIRATION DATE HAD PASSED.