BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORDENT

    MDR report key: 6553593 · Received May 9, 2017

    Report

    Report Number
    6553593
    Event Type
    Malfunction
    Date Received
    May 9, 2017
    Date of Event
    April 7, 2017
    Report Date
    May 3, 2017
    Manufacturer
    NORDENT MFG, INC.
    Product Code
    EMJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING DENTAL EXTRACTIONS, TIP OF THE LUXATOR ELEVATOR BROKE. IT WAS NOTICED BY THE DENTIST IMMEDIATELY. X-RAYS WERE TAKEN AND THE TIP WAS IDENTIFIED AND REMOVED FROM THE TOOTH SOCKET OF THE EXTRACTED TOOTH. THE INSTRUMENT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334797 NORDENT DENTAL ELEVATOR EMJ NORDENT MFG, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR