Description of Event or Problem · 0
IT WAS REPORTED THAT DURING ORTHOPEDIC SURGERY THAT AN EXPIRED MG OSTEOCRETE PRODUCT WAS IMPLANTED IN THE PATIENT. AFTER IMPLANTATION, AND UPON RECEIPT OF CASE PAPERWORK, IT WAS NOTED BY THE MANUFACTURER THAT THE PRODUCT HAD AN EXPIRATION DATE OF (B)(6) 2023. THE SURGEON AND DISTRIBUTOR WERE MADE AWARE OF THE ISSUE AFTER THE SURGERY AND NO FURTHER ACTION WAS TAKEN. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS REPORTED AS STABLE. THE DEVICE WAS RELEASED FROM STERILIZATION ON (B)(6) 2021. EXPIRATION DATES ARE BASED ON THE STERILE SHELF OF THE DEVICE, WHICH WAS VALIDATED FOR TWO YEARS FROM THE DATE OF STERILIZATION. HOWEVER, THE EXPIRATION DATE NOTED ON THE PRODUCT IS GIVEN AT THE TIME OF PACKAGING, WHICH IS 30 DAYS PRIOR TO STERILIZATION. THIS IS TO ALLOW FOR ADEQUATE TIME TO RETRIEVE THE EXPIRING PRODUCT FORM THE FIELD.