BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN-OVATION R BRACKETS

    MDR report key: 862297 · Received June 8, 2007

    Report

    Report Number
    2418500-2007-00128
    Event Type
    Injury
    Date Received
    June 8, 2007
    Date of Event
    April 26, 2007
    Report Date
    May 11, 2007
    Manufacturer
    DENTSPLY GAC INTERNATIONAL
    Product Code
    EJF
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS NOT KNOWN FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    A DOCTOR EXPRESSED CONCERN WITH WEARING OF THE LOWER ANTERIOR TEETH CAUSED BY CONTACT WITH IN-OVATION R BRACKETS ON THE UPPER ARCH. THOUGH THE COMPLAINANT INDICATES WEARING WAS ON THE LOWER ANTERIOR TEETH, PHOTOGRAPHS PROVIDED SHOW VISIBLE WEARING ON THE UPPER TEETH, THE SHAPE OF WHICH APPEARS TO CORRESPOND WITH BRACKETS PLACED ON THE LOWER ARCH. THE BRACKETS ARE STILL IN PLACE AS OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IN-OVATION R BRACKETS EJF DENTSPLY GAC INTERNATIONAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention