BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    -

    MDR report key: 729607 · Received June 21, 2005

    Report

    Report Number
    2081322-2005-00002
    Event Type
    Malfunction
    Date Received
    June 21, 2005
    Date of Event
    May 24, 2005
    Report Date
    June 20, 2005
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    DYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    H3 EVALUATION SUMMARY: IN 06/2005, ORTHO ORGANIZERS RECEIVED THE BROKEN NITANIUM PALATAL EXPANDER INVOLVED IN THIS EVENT. THE VISUAL EXAMINATION SHOWED THAT THE RIGHT ORTHOLOY ARM (WIRE) HAS BROKEN WHERE IT COMES OUT OF THE END INSERT. SCANNING ELECTRON MICROSCOPY (SEM) OF THE FRACTURE SURFACE REVEALED THAT THE FRACTURE MODE INVOLVED THREE ZONES: A BRITTLE OR INTERGRANUAL ZONE NEAR THE SURFACE OF THE WIRE FOLLOWED BY A FATIGUE ZONE AND OVERLOAD ZONE. THE CAUSE FOR THE FORMATION OF THE BRITTLE ZONE HAS NOT BEEN DETERMINED. AS A PREVENTIVE MEASURE, TWO PROOF TESTING STEPS ARE ADDED TO THE MANUFACTURING PROCESS TO ELIMINATE POTENTIALLY WEAK APPLIANCES. WE HAVE BEEN MARKETING THESE APPLIANCES FOR ALMOST 10 YEARS. THE BREAKAGE OF THE ORTHOLOY ARM IS AN EVENT WITH A LOW RATE OF OCCURRENCE.

    Description of Event or Problem · 1

    PATIENT FELT THAT A PIECE OF A NITANIUM PALATAL EXPANDER WAS ABOUT TO BREAK. SHE REMOVED THE BROKEN PIECE FROM HER MOUTH AND INFORMED THE ORTHODONTIST. THE BROKEN PIECE WAS A WIRE SEGMENT (APPROXIMATELY 1" LONG X .036" DIAMETER). NO MEDICAL INTERVENTION WAS NEEDED AND THE INCIDENT HAD NO CONSEQUENCE OR IMPACT TO THE PATIENT AND HAD NO COMPLICATIONS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 - ORTHODONTIC INTRAORAL APPLIANCE DYJ ORTHO ORGANIZERS, INC. 101-767 554039A05

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR ORTHO BANDS LINGUAL SHEATH| DATE TREATMENT BEGAN 2005| WILLIAMS EXPANDER BUILT BY SPACE MAINTAINERS INC