BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNTHES

    MDR report key: 206721 · Received January 19, 1999

    Report

    Report Number
    MW1015463
    Event Type
    Malfunction
    Date Received
    January 19, 1999
    Date of Event
    January 4, 1999
    Report Date
    January 7, 1999
    Manufacturer
    SYNTHES
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM THE MFR ON 02/09/1999: UPON FURTHER INVESTIGATION OF THE DETAILS SURROUNDING THIS EVENT, THE CO DOES NOT BELIEVE THAT THIS IS REPORTABLE UNDER THE MDR GUIDELINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES DRILL BIT HTW SYNTHES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR