BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORTHONOL NICKEL TITANIUM PREFORMED NATURAL ARC

    MDR report key: 2850684 · Received November 27, 2012

    Report

    Report Number
    1718476-2012-00001
    Event Type
    Other
    Date Received
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    RMO, INC.
    Product Code
    DZC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE TESTED WIRE MET ALL PERFORMANCE SPECIFICATIONS AND PRODUCT EMPIRICAL COMPARISON TESTS OF THE MANUFACTURER, AND SHOWED NO SIGNS OF BEING DEFECTIVE. DURING REVIEW OF THE WIRE BREAKAGE SITE, NO EVIDENCE WAS FOUND OF A CAUSE FOR PREMATURE FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT IN (B)(6), UNDERGOING ORTHODONTIC TREATMENT, HAD A LOWER .014 INCH DIAMETER NICKEL TITANIUM SUPER ELASTIC ARCHWIRE BREAK. THE PT SWALLOWED THE SMALL PIECE OF BROKEN WIRE SECTION APPROXIMATELY .75 INCHES IN LENGTH. THE REMAINING SECTION OF WIRE WAS REMOVED AND NEW WIRE REPLACED BY THE ORTHODONTIST. THE PT WAS TAKEN TO EMERGENCY WHERE IMAGING WAS DONE TO DETERMINE THAT THE WIRE HAD REACHED THE PT'S STOMACH. A LATER IMAGING SHOWED THE WIRE HAD PASSED OUT OF THE PT'S SYSTEM. THERE IS NO INDICATION THAT THIS CAUSED ANY HEALTH PROBLEMS FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHONOL NICKEL TITANIUM PREFORMED NATURAL ARC ORTHODONTIC ARCH WIRE DZC RMO, INC. A0720 F1119109

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR