BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNAPLINK BUCCAL TUBE

    MDR report key: 3296301 · Received August 19, 2013

    Report

    Report Number
    2016150-2013-00099
    Event Type
    Injury
    Date Received
    August 19, 2013
    Report Date
    August 6, 2013
    Manufacturer
    ORMCO CORPORATION
    Product Code
    DZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR HAD IDENTIFIED TWO (2) SNAPLINK BUCCAL TUBES WHICH WERE 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 TUBES, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE DEVICES INVOLVED IN THE ALLEGED INCIDENT WERE NOT RETURNED AND NO LOT NUMBERS WERE PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR HAD ALLEGED THAT THE DOORS OF THE SNAPLINK BUCCAL TUBES WOULD NOT STAY CLOSED OR HAD BROKEN OFF, CAUSING THE MOLARS TO ROTATE ONE (1) PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399803 SNAPLINK BUCCAL TUBE ORTHODONTIC TUBE DZD ORMCO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other| R