BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIBOND XTR

    MDR report key: 3191204 · Received June 26, 2013

    Report

    Report Number
    2024312-2013-00308
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 19, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    KLE
    PMA / PMN Number
    K101423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE PATIENT IS DOING FINE; TWO (2) VENEERS WERE RE-CEMENTED USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATIONS CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THREE (3) PATIENTS EXPERIENCED THE DEBONDING OF VENEERS AFTER PLACEMENT WITH OPTIBOND XTR ADHESIVE. THIS IS THE THIRD OF THREE (3) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290799 OPTIBOND XTR TOOTH BONDING RESIN KLE KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R NX3 CEMENT