BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITANIUM PALATAL EXPANDER

    MDR report key: 729594 · Received June 21, 2005

    Report

    Report Number
    2081322-2005-00001
    Event Type
    Malfunction
    Date Received
    June 21, 2005
    Date of Event
    May 24, 2005
    Report Date
    June 20, 2005
    Manufacturer
    ORTHODONTIC INTRAORAL APPLIANCE
    Product Code
    DYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IN 06/2005, ORTHO ORGANIZERS RECEIVED THE BROKEN NITANIUM PALATAL EXPANDER INVOLVED IN THIS EVENT. 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 WAS PURE FATIGUE. FATIGUE CRACK ORIGINATED AT THE SURFACE OF WIRE THAT GREW TO CRITICAL SIZE LEADING TO THE CATASTROPHIC FAST FRACTURE. A HIGH MAGNIFICATION SEM PICTURE REVEALS MULTIPLE STRIATIONS (INDICATION OF FATIGUE FRACTURE) - AN INDICATION OF MULTIPLE LOADING/UNLOADING CYCLES. THE LOCATION OF THE CRACK INDICATES A STRESS CONCENTRATION POINT DUE TO LATERAL FLEXURE OF THE ORTHOLOY ARM. 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 ORTHOLOY ARM IS AN EVENT WITH A LOW RATE OF OCCURRENCES (LESS THAN 0.02%). RADIOGRAPHY RESULTS APPROXIMATELY ONE WEEK AFTER THE INCIDENCE REVEALED "ALL CLEAR" AND NO RADIOPAQUE FOREIGN BODY WAS FOUND. CONCLUSION: AS A RESULT OF THE INCIDENT, THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT.

    Description of Event or Problem · 1

    A WIRE PIECE IS MISSING FROM A NITANIUM PALATAL EXPANDER. UPON EXAMINATION, THE ORTHODONTIST CONFIRMED THAT A WIRE PIECE (APPROXIMATELY 1" LONG X .036" DIAMETER) HAS BROKEN OFF AND MISSING FROM THE EXPANDER. THE ORTHODONTIST WAS CONCERNED THAT THE PATIENT MIGHT HAVE SWALLOWED THE BROKEN WIRE. A SINGLE VIEW CHEST AND ABDOMEN X-RAY WAS PERFORMED APPROXIMATELY A WEEK AFTER THE INCIDENT. ACCORDING TO THE ORTHODONITIST, X-RAY REVEALED "ALL CLEAR" AND NO RADIOPAQUE FOREIGN BDOY WAS FOUND. NO INJURY OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NITANIUM PALATAL EXPANDER ORTHODONTIC INTRAORAL APPLIANCE DYJ ORTHODONTIC INTRAORAL APPLIANCE 101-766 554042A05

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR ORTHODONTIC BANDS LINGUAL SHEATH DATE TREATMENT| WILLIAMS EXPANDER BUILT BY SPACE MAINTAINERS INC