BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES

    MDR report key: 1190217 · Received October 7, 2008

    Report

    Report Number
    MW5008558
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 29, 2008
    Manufacturer
    SYNTHES
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2008, A SYNTHES 8 HOLE PLATE CATALOG# 241.381 AND (1) # 15 SCREW, (2) # 14 SCREWS AND (2) #12 SCREWS WERE UTILIZED IN AN OPEN REDUCTION, AND INTERNAL FIXATION OF A RIGHT FRACTURED CLAVICLE. PT RETURNED FOR SURGERY AT APPROXIMATELY 35 DAYS FOR ORIF OF RIGHT CLAVICLE DUE TO THE FACT, THE PLATE HAD BROKE IN HALF. PT DENIED ANY CONTRIBUTING FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES PLATE HRS SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization