BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRIT MB

    MDR report key: 3679839 · Received March 14, 2014

    Report

    Report Number
    2016150-2014-00023
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Report Date
    February 14, 2014
    Manufacturer
    ORMCO CORPORATION
    Product Code
    DYW
    PMA / PMN Number
    K943245
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INJURIES WERE ASSOCIATED WITH THIS INCIDENT. THE DOCTOR NOTICED THE MARKING WAS IN THE WRONG AREA AND STOPPED USING THE DEVICE. PICTURES OF THE PRODUCT ALLEGED IN THIS INCIDENT CONFIRMED THAT THE IDENTIFICATION DOT IS LOCATED ON THE INCORRECT AREA OF THE BRACKET. A RETAIN SAMPLE OF THE PRODUCT WAS EVALUATED, YIELDING RESULTS WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    SYBRONENDO CORPORATION WAS INFORMED ON 04/14/2014 BY A DEALER REPRESENTATIVE THAT THE WRONG ITEM NUMBER AND DESCRIPTION WAS GIVEN ON THE INITIAL COMPLAINT REPORT. THE CORRECT ITEM NUMBER INVOLVED IN THE ALLEGED INCIDENT IS 202-0069 AND THE DESCRIPTION IS CHANNELS 21MM FILES.

    Description of Event or Problem · 1

    A DEALER REPORTED THAT A DOCTOR'S OFFICE ALLEGED THAT SPIRIT MB IDENTIFICATION DOT IS LOCATED ON THE INCORRECT AREA OF THE BRACKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152852 SPIRIT MB ORTHODONTIC BRACKET, PLASTIC DYW ORMCO CORPORATION 081351013

    Patients

    Seq Age Sex Outcome Treatment
    1