BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN ¿ IMPLANT

    MDR report key: 14550298 · Received May 31, 2022

    Report

    Report Number
    2027971-2022-074947
    Event Type
    Death
    Date Received
    May 31, 2022
    Report Date
    May 31, 2022
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM. THE INITIAL REPORT DID NOT HAVE THE CORRECT OUTCOMES ATTRIBUTED TO ADVERSE EVENT - DEATH, THE CORRECT ONE - REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES)IS PROVIDED IN THIS FOLLOW-UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2810149 UNKNOWN ¿ IMPLANT ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Death| R