BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFILE GT ROTARY INSTRUMENT

    MDR report key: 691381 · Received March 22, 2006

    Report

    Report Number
    2320721-2006-00095
    Event Type
    Malfunction
    Date Received
    March 22, 2006
    Date of Event
    August 16, 2005
    Report Date
    February 20, 2006
    Manufacturer
    DENTSPLY TULSA
    Product Code
    DZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A FILE SEPERATED IN THE CANAL DURING A PROCEDURE.CANAL WAS FILLED WITH THE SEPERATED PIECE IN PLACE WITHOUT SEQUELA.IT WAS ALSO REPORTED THAT TWO OTHER FILE SEPERATION EVENTS OCCURRED,THROUGH NO FUTHER DETAIL WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILE GT ROTARY INSTRUMENT DENTAL FILE DZA DENTSPLY TULSA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR