BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIBOND SOLO PLUS

    MDR report key: 2945914 · Received February 6, 2013

    Report

    Report Number
    2024312-2013-00037
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 15, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    KLE
    PMA / PMN Number
    K990498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO GENDER AND AGE WERE NOT PROVIDED BY THE DOCTOR. THE CROWN FOR TOOTH NUMBER FIFTEEN (15) WAS RE-CEMENTED USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCTS USED IN THESE INCIDENTS WERE NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATIONS CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT FIVE (5) PATIENTS HAD EXPERIENCED THE DEBONDING OF CROWNS AFTER PLACEMENT WITH OPTIBOND SOLO PLUS. THIS IS THE FIRST OF FIVE (5) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50016 OPTIBOND SOLO PLUS RESIN TOOTH BONDING AGENT KLE KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R PENTRON BUILD IT FR