BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4R ELEV.

    MDR report key: 2151432 · Received June 21, 2011

    Report

    Report Number
    2523190-2011-00045
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    INTEGRA, YORK - IMILTEX
    Product Code
    EMJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ITEM HAS BROKEN TIPS. ON (B)(6), 2011, ADDITIONAL INFO WAS RECEIVED FROM THE DENTAL ASSISTANT. SHE STATED THE DEVICE FRACTURED DURING A TOOTH EXTRACTION OF THE LEFT THIRD MOLAR IN WHICH THE DENTIST WAS USING THE DEVICE IN THE PROPER MANNER IN WHICH THE ELEVATOR SHOULD BE USED WHEN EXTRACTING A TOOTH. THERE WAS NO PT INJURY. A DENTAL DAM (OR OTHER PROTECTIVE DEVICE) WAS NOT BEING USED DURING THE PROCEDURE "BECAUSE THIS NEVER HAPPENED BEFORE". IT WASN'T UNTIL THE ELEVATOR WAS REMOVED FROM THE PT'S MOUTH AND PLACED ON THE DOCTOR'S BRACKET TABLE THAT THE PIECE FELL OFF. HOWEVER, THE DENTAL ASSISTANT REPORTED THE DENTIST FELT THERE WAS THE POTENTIAL FOR THE TIP TO GO DOWN THE PT'S THROUGH AND CAUSE HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4R ELEV. M51 - GENERAL DENTISTRY EMJ INTEGRA, YORK - IMILTEX

    Patients

    Seq Age Sex Outcome Treatment
    1