BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRANEMARK SYSTEM

    MDR report key: 38536 · Received August 28, 1996

    Report

    Report Number
    1220857-1996-00005
    Event Type
    Injury
    Date Received
    August 28, 1996
    Date of Event
    July 23, 1996
    Report Date
    July 31, 1996
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT TWO ABUTMENT SCREWS FRACTURED WITHIN TWO IMPLANTS. THE SCREWS WERE REMOVED. THE FIXTURES ARE STILL IN THE PT'S MOUTH. NO PT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRANEMARK SYSTEM Implant DENTAL IMPLANT DZE NOBEL BIOCARE AB SDCA137 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention