Description of Event or Problem · 0
IT WAS REPORTED THAT DURING ORTHOPEDIC SURGERY THAT AN EXPIRED MG OSTEOCRETE PRODUCT WAS IMPLANTED IN THE PT. AFTER IMPLANTATION AND UPON RECEIPT OF CASE PAPERWORK, IT WAS NOTED BY THE MFR THAT THE PRODUCT HAD AN EXPIRATION DATE OF 04/14/2023. 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 PT WAS REPORTED AS STABLE. THE DEVICE WAS RELEASED FROM STERILIZATION ON (B)(6) 2021. EXP DATES ARE BASED ON THE STERILE SHELF LIFE OF THE DEVICE, WHICH WAS VALIDATED FOR TWO YEARS FROM THE DATE OF STERILIZATION. HOWEVER, THE EXP DATE NOTED ON THE PRODUCT IS GIVEN AT THE TIME OF PACKAGING, WHICH IS 30 DAYS PRIOR TO STERILIZATION. THIS IS TO ALLOW ADEQUATE TIME TO RETRIEVE EXPIRING PRODUCT FROM THE FIELD.