BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3832148 · Received May 7, 2014

    Report

    Report Number
    3025141-2014-00073
    Event Type
    Injury
    Date Received
    May 7, 2014
    Report Date
    April 8, 2014
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MDRS ASSOCIATED WITH THIS EVENT: MDR 3025141-2014-00067: PLATE P/N 70-0029, MDR 3025141-2014-00068: SCREW #1, MDR 3025141-2014-00069: SCREW #2, MDR 3025141-2014-00070: SCREW #3, MDR 3025141-2014-00071: SCREW #4, MDR 3025141-2014-00072: SCREW #5, MDR 3025141-2014-00074: SCREW #7, MDR 3025141-2014-00075: SCREW #8, MDR 3025141-2014-00076: SCREW #9, MDR 3025141-2014-00077: SCREW #10 AND MDR 3025141-2014-00078: SCREW #11.

    Description of Event or Problem · 1

    A FRACTURED TIBIA WAS PLATED WITH A MEDIAL TIBIA PLATE ON (B)(6) 2013. THE PLATE BROKE AND WAS EXPLANTED (ALONG WITH THE SCREWS) ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274800 SCREW, FIXATION, BONE HWC ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention