BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9611993-2024-111732

    MDR report key: 20316464 · Received September 26, 2024

    Report

    Report Number
    9611993-2024-111732
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    April 16, 2024
    Manufacturer
    NOBEL BIOCARE (PRODUCTION) AB
    Product Code
    DZE
    PMA / PMN Number
    K022562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1490905 DZE NOBEL BIOCARE (PRODUCTION) AB

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention