BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3959797 · Received July 11, 2014

    Report

    Report Number
    3025141-2014-00155
    Event Type
    Injury
    Date Received
    July 11, 2014
    Report Date
    June 12, 2014
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT: 3025141-2014-00148: PLATE, 00151: SCREW 1, 00152: SCREW 2, 00154: SCREW 4, 00155: SCREW 5, 00156: SCREW 6, 00157: SCREW 7, 00158: SCREW 8.

    Description of Event or Problem · 1

    AN IMPLANTED CLAVICLE PLATE BROKE POST OPERATIVELY AND WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407573 SCREW, FIXATION, BONE HRS ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention