BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9611993-2025-053462

    MDR report key: 21501193 · Received March 2, 2025

    Report

    Report Number
    9611993-2025-053462
    Event Type
    Injury
    Date Received
    March 2, 2025
    Date of Event
    June 28, 2024
    Manufacturer
    NOBEL BIOCARE (PRODUCTION) AB
    Product Code
    DZE
    PMA / PMN Number
    K071370
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FAILURE TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586500 DZE NOBEL BIOCARE (PRODUCTION) AB

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention