BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    77R ELEV.-SERR.

    MDR report key: 1723218 · Received June 7, 2010

    Report

    Report Number
    2523190-2010-00004
    Event Type
    Malfunction
    Date Received
    June 7, 2010
    Report Date
    June 7, 2010
    Product Code
    EMJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    DR REPORTED THE WORKING ELEVATOR TIP BROKE OFF INSIDE THE TOOTH SOCKET AND BECAME LODGED IN THE SINUS CAVITY WHILE PERFORMING AN EXTRACTION. DR WAS ABLE TO REMOVE COMPLETE FRACTURED TIP FROM EXTRACTION SITE (SOCKET), DR NOTED THAT THE SINUS CAVITY WAS PERFORATED. A FOLLOW UP APPOINTMENT WAS MADE FOR THE PT FOR THE EXTRACTION SITE. ANTIBIOTICS WERE GIVEN TO THE PT FOR THE EXTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 77R ELEV.-SERR. M51 - GENERAL DENTISTRY EMJ

    Patients

    Seq Age Sex Outcome Treatment
    1