OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY

Additional Manufacturer Narrative

THE STERILE-PACKED PRODUCT HAD AN EXPIRATION DATE OF 11/08/2023, WHICH WAS PURCHASED AND DISTRIBUTED FROM THE MANUFACTURER ON 7/16/2021. FINAL PRODUCT LABELING AFFIXED TO THE PRODUCT CARTON AND GRAFT PACKAGING CLEARLY IDENTIFIES THE EXPIRATION DATE ASSIGNED TO THE PRODUCT IN THE YYYY-MM-DD LABELING FORMAT WITH A DATE FORMAT LEGEND FOR CLARITY AND EASE OF IDENTIFYING THE PRODUCT EXPIRATION DATE. THE PRECAUTIONS SECTION OF THE IFU DISTRIBUTED WITH THE PRODUCT STATES, "THE ALLOGRAFT SHOULD NOT BE USED IF THE EXPIRATION DATE HAS BEEN SURPASSED, THE CONTAINER IN WHICH THE PRODUCT IS STORED IS DAMAGED, THE PRODUCT IS NOT LABELED, OR THE REQUIRED STORAGE CONDITIONS HAVE NOT BEEN MAINTAINED." THE ROOT CAUSE OF THIS EVENT IS A LACK OF STERILE PRODUCT EXPIRATION DATE MANAGEMENT AT THE SURGICAL FACILITY WHERE THE PRODUCT WAS IMPLANTED. THERE HAS BEEN ONE OTHER EVENT OF STERILE-PACKED PRODUCTS IMPLANTED BEYOND THE EXPIRATION DATE IN THE PAST 12 MONTHS FOR LABELING ACTIVITES PERFORMED BY THE MANUFACTURER. THE MANUFACTURER WILL CONTINUE TO MONITOR THE FIELD FOR COMMUNICATIONS OF STERILE-PACKED PRODUCT IMPLANTED BEYOND THE EXPIRATION DATE IDENTIFIED ON THE PRODUCT LABELING.

Description of Event or Problem

THE MANUFACTURER WAS MADE AWARE OF AN EVENT ON 1/24/2024, IN WHICH IT WAS REPORTED A STERILE-PACKED PRODUCT WAS IMPLANTED ON (B)(6) 2024 BEYOND THE EXPIRATION DATE IDENTIFIED ON THE PRODUCT LABEL. THERE WERE NO REPORTED PATIENT COMPLICATIONS OR DELAY IN TREATMENT ASSOCIATED WITH THIS EVENT.