BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPRO GO-EZ SCREW

    MDR report key: 3934640 · Received June 25, 2014

    Report

    Report Number
    1833506-2014-00002
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BIOPRO, INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT STERILE VALIDATION COVERS A (B)(4) PERIOD FOR BLISTERS WITH TYVEK LIDS. PRODUCT WAS IMPLANTED 2 WEEKS AFTER THE VALIDATION WINDOW. BIOPRO PRODUCT PACKAGED WITH (B)(4) HAS BEEN VALIDATED TO (B)(4). TESTING/VALIDATION IS BEING PERFORMED AT THIS TIME TO EXTEND THE STERILITY DATE ON THE BLISTERS. FACILITY FAILED TO HEED THE STERILE EXPIRATION DATE ON THE PRODUCT BOX. AT THIS TIME THE PATIENT HAS HAD NO PROBLEMS.

    Description of Event or Problem · 1

    COMPONENT WAS IMPLANTED AFTER STERILE EXPIRATION DATE. EXPIRATION DATE WAS 12-2013. COMPONENT WAS IMPLANTED ON (B)(6) 2014. FACILITY WAS AWARE OF THIS AND IMPLANTED IT ANYWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371976 BIOPRO GO-EZ SCREW FIXATION SCREW HWC BIOPRO, INC. 18202 109106

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other