BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFILE GT ROTARY INSTRUMENT

    MDR report key: 720871 · Received May 26, 2006

    Report

    Report Number
    2320721-2006-00189
    Event Type
    Malfunction
    Date Received
    May 26, 2006
    Date of Event
    April 27, 2006
    Report Date
    April 27, 2006
    Manufacturer
    DENTSPLY TULSA
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A FILE SEPERATED IN THE CANAL DURING A PROCEDURE. THE CANAL WAS FILLED WITH THE SEPERATED PIECE IN PLACE. NO FURTHER TREATMENT IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILE GT ROTARY INSTRUMENT EKS EKS DENTSPLY TULSA NA 122105011

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR