BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRANEMARK SYSTEM

    MDR report key: 117275 · Received August 29, 1997

    Report

    Report Number
    1220857-1997-02106
    Event Type
    Other
    Date Received
    August 29, 1997
    Date of Event
    August 1, 1997
    Report Date
    August 18, 1997
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS USING A FIXTURE MOUNT TO PLACE AN IMPLANT. THE SURGEON ATTEMPTED TO REMOVE THE FIXTURE FROM THE IMPLANT AND DISCOVERED THAT THE FIXTURE MOUNT FROZE TO THE IMPLANT. DURING THE SAME SURGERY, THE SURGEON THEN REMOVED THE IMPLANT AND THE FIXTURE MOUNT FROM THE SITE. THE SURGEON WAS ABLE TO PLACE A DIFFERENT IMPLANT USING A DIFFERENT FIXTURE MOUNT INTO THE SITE DURING THE SAME SURGERY. 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 DIB007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other