BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NITANIUM PALATAL EXPANDER

    MDR report key: 616064 · Received June 21, 2005

    Report

    Report Number
    2081322-2005-00003
    Event Type
    Injury
    Date Received
    June 21, 2005
    Date of Event
    July 31, 2004
    Report Date
    June 20, 2005
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    DYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN MAY 2005 CO WAS INFORMED BY DISTRIBUTOR THAT A PIECE OF WIRE FROM A NITANIUM PALATAL EXPANDER BROKE IN A PT'S MOUTH AND THE BROKEN PIECE WAS SWALLOWED BY THE PT DURING THE BREAKFAST. THE PT WAS ADMITTED TO THE HOSP AND THE BROKEN PIECE WAS EXTRACTED FROM THE PTS BODY USING A PROCEDURE CALLED "COELIOSCOPY". AFTER THE EXTRACTION PROCEDURE, THE PT RETURNED TO NORMAL LIFE ROUTINE AND THERE WAS NO PERMANENT INJURY TO THE PT. THE INCIDENT HAS BEEN REPORTED TO THE COMPETENT AUTHORITY BY THE DISTRIBUTOR AND A COPY OF THE REPORT WAS PROVIDED TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NITANIUM PALATAL EXPANDER ORTHODONTIC INTRAORAL APPLIANCE DYJ ORTHO ORGANIZERS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention