BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEGUDENT U

    MDR report key: 2058955 · Received March 31, 2011

    Report

    Report Number
    9681199-2011-00001
    Event Type
    Injury
    Date Received
    March 31, 2011
    Report Date
    March 1, 2011
    Manufacturer
    DEGUDENT GMBH
    Product Code
    EJT
    PMA / PMN Number
    K951778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SHOWED THAT THE FRACTURE WAS CAUSED EXCLUSIVELY BY USE ERROR. AS SUCH, THERE IS NO INDICATION THAT THE DEVICE INVOLVED MALFUNCTIONED. HOWEVER, SINCE HEALTHY TOOTH STRUCTURE WAS DAMAGED AND INTERVENTION WAS REQUIRED AS A RESULT, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS RETURNED AND MACROSCOPIC INSPECTION AND MICROSECTION EVALUATIONS WERE PERFORMED. MASSIVE ABRASION, NUMEROUS BLOW HOLES, AND BLOW HOLES IN SOLDER JOINT WERE NOTED. THE CUSTOMER WAS ADVISED TO CHECK AND IMPROVE CASTING PARAMETERS IN ORDER TO ATTAIN BETTER CASTING QUALITY. IN THE CASE OF MASSIVE ABRASION, THE BRIDGE SHOULD BE STABILIZED BY ENLARGING THE CONNECTOR CROSS SECTION AND USING A LINGUAL METAL GARLAND. THE SOLDER FISSURE SHOULD BE KEPT BETWEEN 0.05 AND 0.2 MM.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT A FOUR-PART DEGUDENT U BRIDGE FRACTURED IN A PT'S MOUTH AFTER FOUR YEARS IN PLACE. A TOOTH UNDER THE BRIDGE ALSO FRACTURED. AS A RESULT, THE TOOTH WAS RESTORED; NO FURTHER ISSUES WERE REPORTED AFTER RESTORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEGUDENT U EJT DEGUDENT GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DUCERAM KISS