BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.3MM X 22MM LOCKING CORTICAL SCREW

    MDR report key: 1962523 · Received January 18, 2011

    Report

    Report Number
    3025141-2011-00002
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ACUMED ACU-LOC PLATE WAS EXPLANTED DUE TO A NON-UNION. THE SCREWS WERE BROKEN WHEN REMOVED. ACCORDING TO THE SURGEON, THE SCREWS SEEMED TO BE BROKEN BEFORE THE PLATE WAS REMOVED. THE SURGEON IS NOT ALLEGING A DEFICIENCY WITH THE ACU-LOC PLATE NOR THAT IS CAUSED THE NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.3MM X 22MM LOCKING CORTICAL SCREW PLATE, FIXATION, BONE HRS ACUMED LLC CO-T2322

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention