BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELEVATOR HEIDBRINK DE 13/14

    MDR report key: 692877 · Received March 27, 2006

    Report

    Report Number
    2411236-2006-16107
    Event Type
    Injury
    Date Received
    March 27, 2006
    Date of Event
    February 28, 2006
    Report Date
    February 28, 2006
    Manufacturer
    NOPA INSTRUMENTS
    Product Code
    EKO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE ELEVATOR TIP BROKE OFF IN THE PT'S BONE DURING A TOOTH EXTRACTION. THE DENTIST INQUIRED ABOUT THE PT BEING ABLE TO HAVE AN MRI. THE DR WAS ADVISED AGAINST AN MRI SINCE WE BELIEVE SURGICAL GRADE STAINLESS STEEL MAY BE MAGNETIC. THE BROKEN TIP IS LODGED IN THE PT'S BONE AND WASNOT REMOVED BY THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELEVATOR HEIDBRINK DE 13/14 DENTAL ROOT TIP ELEVATOR EKO NOPA INSTRUMENTS * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention