BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 152713 · Received January 24, 1998

    Report

    Report Number
    MW4002132
    Event Type
    Injury
    Date Received
    January 24, 1998
    Date of Event
    June 9, 1997
    Report Date
    January 22, 1998
    Manufacturer
    UNK
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ABOUT THREE TO FOUR YRS AGO RPTR HAD TWO DENTAL IMPLANTS IN THE LOWER RIGHT JAW. ON JUNE 9, 1997, ONE OF THE POSTS BROKE LEAVING PART OF THE POST IN THE CROWN AND PART IN BASE. ON JUNE 25, 1997 THE PIECE IN THE BASE OF THE IMPLANT WAS DRILLED OUT AND A NEW POST INSTALLED. ON DECEMBER 25, 1997, THE OTHER IMPLANT BECAME LOOSE. THE END RESULT WAS THAT ON JANUARY 3, 1998, THE IMPLANT CAME OUT AND HAD BROKEN OFF JUST AS THE FIST ONE HAD. AS OF THIS DATE RPTR IS WAITING TO HEAR WHEN THE PIECE WILL BE DRILLED OUT AND A NEW POST INSTALLED. THE PURPOSE OF THE LETTER IS TO ALERT THE PUBLIC THAT THERE IS DANGER THAT THE POST MAY BREAK RESULTING IN PAIN AND EXPENSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK Implant DENTAL IMPLANT DZE UNK UNK UNK
    2 UNK Implant DENTAL IMPLANT DZE UNK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN