BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFILE GT ROTARY FILE

    MDR report key: 509767 · Received January 13, 2004

    Report

    Report Number
    2320721-2004-00008
    Event Type
    Malfunction
    Date Received
    January 13, 2004
    Date of Event
    December 11, 2003
    Report Date
    December 15, 2003
    Manufacturer
    DENTSPLY TULSA DENTAL
    Product Code
    DZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR REPORTED SEPARATING A FILE IN A PT'S TOOTH. THE PT WAS REFERRED TO AN ENDODONTIST FOR FURTHER TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other