BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPRO GREAT TOE MP JOINT

    MDR report key: 3839180 · Received May 15, 2014

    Report

    Report Number
    1833506-2014-00001
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 15, 2014
    Manufacturer
    BIOPRO, INC.
    Product Code
    KWD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY IMPLANTED THE COMPONENT AFTER THE STERILE EXPIRATION DATE. THEY WERE NOT AWARE OF THIS. CUSTOMER SERVICE AT MANUFACTURER NOTICED THIS WHEN THE ORDER WAS FAXED IN AND DATE WAS ON PATIENT STICKER. CURRENT STERILIZATION VALIDATION WINDOW GIVES A LEEWAY OF 5 MONTHS AFTER EXPIRATION DATE. THEREFORE, MANUFACTURER IS CONFIDENT THAT COMPONENT WAS STILL STERILE.

    Description of Event or Problem · 1

    COMPONENT WAS IMPLANTED AFTER STERILE EXPIRATION DATE. EXPIRATION DATE WAS ON 04/2014 AND PRODUCT WAS IMPLANTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289517 BIOPRO GREAT TOE MP JOINT TOE JOINT KWD BIOPRO, INC. 10060 107471

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other