BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFILE NT ROTARY INSTRUMENT

    MDR report key: 614983 · Received June 17, 2005

    Report

    Report Number
    2320721-2005-00222
    Event Type
    Malfunction
    Date Received
    June 17, 2005
    Date of Event
    May 20, 2005
    Report Date
    May 20, 2005
    Manufacturer
    DENTSPLY TULSA
    Product Code
    DZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT A FILE SEPERATED IN THE CANAL DURING PROCEDURE. THE PT IS SCHEDULED FOR FOLLOW-UP TREATMENT AT WHICH TIME THE DOCTOR PLANS TO ATTEMPT RETRIEVAL OF THE SEPERATED PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILE NT ROTARY INSTRUMENT DENTAL FILE DZA DENTSPLY TULSA NA 041205019

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR