BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.7 X 34MM LOCKING SCREW

    MDR report key: 3666591 · Received December 9, 2013

    Report

    Report Number
    3025141-2013-00204
    Event Type
    Injury
    Date Received
    December 9, 2013
    Report Date
    November 11, 2013
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDR ASSOCIATED WITH THIS EVENT: 3025141-2013-00205: 30-0440-SCREW.

    Description of Event or Problem · 1

    TWO SCREWS BACKED OUT OF A PLATE A FEW MONTHS POST OPERATIVELY. SURGERY WAS PERFORMED TO REMOVE THE BACKED OUT SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639415 5.7 X 34MM LOCKING SCREW SCREW, FIXATION, BONE, PRODUCT CODE: HRS HRS ACUMED LLC 30-0434

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention