BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRANEMARK SYSTEM

    MDR report key: 110389 · Received August 1, 1997

    Report

    Report Number
    1220857-1997-01757
    Event Type
    Injury
    Date Received
    August 1, 1997
    Date of Event
    May 8, 1997
    Report Date
    June 26, 1997
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    FAILURE TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRANEMARK SYSTEM Implant DENTAL IMPLANT DZE NOBEL BIOCARE AB SDCA665 528153

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention