BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES

    MDR report key: 1812496 · Received August 17, 2010

    Report

    Report Number
    MW5017176
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 17, 2010
    Manufacturer
    SYNTHES INC.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TWO 12 MM SCREWS WERE ATTEMPTED TO BE PLACED IN THE RIGHT INFERIOR MANDIBLE INDIVIDUALLY AND BOTH BROKE OFF AT 9MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES SCREW 2.0 IMF 12MM HWC SYNTHES INC. LOG214066

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR