BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHONOL NICKEL TITANIUM ARCH .014" MANDIBULAR

    MDR report key: 623170 · Received July 27, 2005

    Report

    Report Number
    1718476-2005-00001
    Event Type
    Injury
    Date Received
    July 27, 2005
    Date of Event
    April 16, 2005
    Report Date
    June 28, 2005
    Manufacturer
    RMO, INC.
    Product Code
    DZC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    MARCH 2005: ORTHONOL WIRE ATTACHED. ABOUT TWO WEEKS PT WAS AT HOME DINING WHEN THE WIRE BROKE AND THE PT SWALLOWED THE BROKEN WIRE. THE NEXT DAY DOCTOR OFFICE CLOSED. THE NEXT DAY PT VISITED THE DOCTOR OFFICE. PT WAS TAKEN TO THE HOSP WHERE IT WAS FOUND THAT THE BROKEN WIRE HAD REACHED THE PT'S STOMACH. THE BROKEN PIECES OF WIRE WAS REMOVED BY AN ENDOSCOPE AT THE HOSP. THE ARCH WIRE WAS USED FOR LEVELING AND #6 AND #8 MANDIBULAR SPACE CLOSING (#7 SECONDS MOLAR WAS MISSING). THE DOCTOR PURCHASED THE WIRE ABOUT 4 YEARS AGO, HOWEVER THE DOCTOR DID NOT RETAIN THE PACKAGING, THEREFORE THE LOT NUMBER IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHONOL NICKEL TITANIUM ARCH .014" MANDIBULAR ORTHODONTIC ARCH WIRE DZC RMO, INC. A07020 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R