BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-FLEXOREAMER

    MDR report key: 644809 · Received November 4, 2005

    Report

    Report Number
    8031010-2005-00459
    Event Type
    Injury
    Date Received
    November 4, 2005
    Report Date
    October 5, 2005
    Manufacturer
    DENTSPLY DETREY-DEDENT
    Product Code
    DZP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FILE SEPARATED IN THE CANAL DURING A PROCEDURE. AS A RESULT, THE TOOTH WAS EXTRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-FLEXOREAMER DENTAL HAND INSTRUMENT DZP DENTSPLY DETREY-DEDENT NA 3224B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention