BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRANEMARK SYSTEM

    MDR report key: 92032 · Received May 16, 1997

    Report

    Report Number
    1220857-1997-01129
    Event Type
    Other
    Date Received
    May 16, 1997
    Date of Event
    April 22, 1997
    Report Date
    May 6, 1997
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE SURGEON WAS USING A FIXTURE MOUNT TO PLACE AN IMPLANT. WHEN THE SURGEON ATTEMPTED TO REMOVE THE FIXTURE MOUNT FROM THE IMPLANT, THE SURGEON DISCOVERED THAT THE FIXTURE MOUNT WOULD NOT RELEASE FROM THE IMPLANT. THE SURGEON THEN REMOVED THE IMPLANT FROM THE SITE WITH THE ATTACHED FIXTURE MOUNT. DURING THE SAME PROCEDURE, THE SURGEON WAS ABLE TO PLACE ANOTHER IMPLANT USING A DIFFERENT FIXTURE MOUNT AND IMPLANT. PT INJURY HAS NOT BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRANEMARK SYSTEM Implant DENTAL IMPLANT DZE NOBEL BIOCARE AB DIA224 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other