BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 645395 · Received November 1, 2005

    Report

    Report Number
    MW4004043
    Event Type
    Injury
    Date Received
    November 1, 2005
    Date of Event
    April 14, 2005
    Report Date
    September 28, 2005
    Manufacturer
    SYNTHES INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT EXPLANT OF PLATE AND SCREWS DUE TO PLATE BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * FIXATION PLATE & SCREWS HRS SYNTHES INC. 10 HOLE PLATE *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention