BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPBOND

    MDR report key: 3094018 · Received May 6, 2013

    Report

    Report Number
    1815757-2013-00004
    Event Type
    Injury
    Date Received
    May 6, 2013
    Report Date
    April 9, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE NO EVALUATIONS CAN BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2012, THE BRIDGE HAD DEBONDED WHILE THE COMPLAINANT WAS TRAVELING TO EUROPE; THE DENTIST RE-CEMENTED THE BRIDGE USING TEMPBOND. ON (B)(6) 2012, THE COMPLAINANT VISITED HER DENTIST ATTEMPTED TO REMOVED THE BRIDGE; HOWEVER, THE DENTIST COULD NOT REMOVE THE BRIDGE. ON (B)(6) 2013, THE PATIENT MET WITH HER DENTIST AND DETERMINED THAT THEY WILL REMOVE THE BRIDGE. ON (B)(6) 2013, THE PATIENT RETURNED TO HAVE HER UPPER BRIDGE REMOVED. TO DATE, THE PATIENT IS DOING FINE. THE COMPLAINANT WILL RETURNED IN APPROXIMATELY A MONTH TO SEE IF SHE NEEDS HER LOWER BRIDGE REMOVED. REGULATORY AFFAIRS WILL UPDATE THIS COMPLAINT IF FURTHER INFORMATION IS RECEIVED. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATIONS CAN BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, THE BRIDGE HAD DEBONDED WHILE TRAVELING TO EUROPE; THE DENTIST RE-CEMENTED THE BRIDGE USING TEMPBOND.

    Description of Event or Problem · 1

    A COMPLAINANT ALLEGED THAT SHE HAD EXPEREINCED TMJ AFTER A LOWER PERMANENT BRIDGE WAS PLACED USING TEMPBOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196293 TEMPBOND CEMENT, DENTAL EMA KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other