BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIBOND SOLO PLUS

    MDR report key: 3223027 · Received July 12, 2013

    Report

    Report Number
    2024312-2013-00354
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 19, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    KLE
    PMA / PMN Number
    K991808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARD TO AGE, GENDER, AND WEIGHT WAS NOT PROVIDED. THE DOCTOR REPORTED THAT HE HAD EITHER CLEANED OUT THE CROWN AND RE-SEATED IT USING A DIFFERENT PRODUCT, OR CEMENTED A NEW CROWN FOR THE PATIENT USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT APPROXIMATELY TEN (10) PATIENTS HAD EXPERIENCED EITHER CEMENT LOSS FROM UNDER THE CROWN, OR A PART OF THE CROWN BREAKING, OR A LOSS OF A CROWN APPROXIMATELY TWO (2) YEARS AFTER PLACEMENT WITH OPTIBOND SOLO PLUS; HOWEVER, SPECIFIC INCIDENT DETAILS COULD NOT BE RECALLED. THIS IS THE THIRD OF TEN (10) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324337 OPTIBOND SOLO PLUS RESIN TOOTH BONDING AGENT KLE KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R NX3 DUAL CURE CLEAR