BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 3728713 · Received April 7, 2014

    Report

    Report Number
    2016150-2014-00025
    Event Type
    Injury
    Date Received
    April 7, 2014
    Report Date
    March 25, 2014
    Manufacturer
    ORMCO CORPORTATION
    Product Code
    DYW
    PMA / PMN Number
    K121524
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE PATIENT IS DOING FINE. THE DOCTOR PERFORMED A ROOT CANAL TRETAMENT, APICOECTOMY AND PERIODNTAL SURGERY FOR THE PATIENT. A NE DEVICE AS PLACED FOR THE PATIENT. THE PRODUCT AS NOT RETURNED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT TWO (2) PATIENT HAD EXPERIENCED UNEXPECTED TEETH MOVEMENT AFTER PLACEMENT WITH INSIGNIA SINGLE PATIENT KIT. THIS IS THE SECOND OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208656 INSIGNIA ORTHODONTIC PLASTIC BRACKET DYW ORMCO CORPORTATION 19803

    Patients

    Seq Age Sex Outcome Treatment
    1 39 Other| R