BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3984602 · Received August 6, 2014

    Report

    Report Number
    3025141-2014-00190
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 10, 2014
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT:MDR 3025141-2014-00185 SCREW 1,MDR 3025141-2014-00186 SCREW 2,MDR 3025141-2014-00187 SCREW 3,MDR 3025141-2014-00188 SCREW 4,MDR 3025141-2014-00189 SCREW 5,MDR 3025141-2014-00191 SCREW 7,MDR 3025141-2014-00192 SCREW 8,MDR 3025141-2014-00193 SCREW 9,MDR 3025141-2014-00194 PLATE.

    Description of Event or Problem · 1

    ONE SCREW IN AN IMPLANTED CLAVICLE PLATE BROKE POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460538 SCREW, FIXATION, BONE HRS ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1