BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNAPLINK BUCCAL TUBE

    MDR report key: 3287423 · Received August 14, 2013

    Report

    Report Number
    2016150-2013-00094
    Event Type
    Injury
    Date Received
    August 14, 2013
    Report Date
    August 6, 2013
    Manufacturer
    ORMCO CORPORATION
    Product Code
    DZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO GENDER, AGE, AND WEIGHT WERE NOT PROVIDED BY THE DOCTOR. ALTHOUGH THE DOCTOR IDENTIFIED TWO DIFFERENT SNAPLINK CATALOG NUMBERS ASSOCIATED WITH THE ROTATION OF THE PATIENT'S MOLAR, HE COULD NOT VERIFY WHICH CATALOG NUMBER WAS USED ON THE PATIENT; THEREFORE, NO CATALOG NUMBERS WERE IDENTIFIED IN THIS REPORT. THE CATALOG NUMBERS INVOLVED IN THE ALLEGED INCIDENT INCLUDE 438-2191 AND 438-2190. THE DOCTOR REPLACED THE PATIENT'S BUCCAL TUBE, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE DEVICE INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT APPROXIMATELY TWENTY (20) PATIENTS HAD EXPERIENCED THE ROTATION OF A LOWER FIRST MOLAR AFTER THE DOORS OF THE SNAPLINK BUCCAL TUBES HAD BROKEN. THIS IS THE EIGHTEENTH OF TWENTY (20) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391067 SNAPLINK BUCCAL TUBE ORTHODONTIC TUBE DZD ORMCO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R