BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTAPER NT ROTARY FILE

    MDR report key: 523795 · Received February 17, 2004

    Report

    Report Number
    8031010-2004-00086
    Event Type
    Malfunction
    Date Received
    February 17, 2004
    Date of Event
    January 22, 2004
    Report Date
    January 22, 2004
    Manufacturer
    DENTSPLY TULSA
    Product Code
    DZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR REPORTED SEPARATING A FILE IN A PT'S TOOTH DURING A DENTAL PROCEDURE. PT FOLLOW-UP WILL BE REQUIRED AND REPORTED AS THE INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other