BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABIDENT DENTAL TREPHINE

    MDR report key: 44560 · Received October 24, 1996

    Report

    Report Number
    MW1010145
    Event Type
    Malfunction
    Date Received
    October 24, 1996
    Date of Event
    September 30, 1996
    Report Date
    October 23, 1996
    Manufacturer
    FAIRFAX DENTAL, INC.
    Product Code
    DZM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    WIRE PERFORATOR SEPARATED FROM PLASTIC HUB LEAVING WIRE PERFORATOR EMBEDDED IN BONE AND SOFT TISSUE OF MANDIBLE. WIRE WAS REMOVED BY GRASPING PROTRUDING PORTION WITH HEMOSTATS. WIRE PERFORATOR WAS REMOVED INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABIDENT DENTAL TREPHINE DENTAL TREPHINE DZM FAIRFAX DENTAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *