BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2027971-2026-033468

    MDR report key: 24106198 · Received January 17, 2026

    Report

    Report Number
    2027971-2026-033468
    Event Type
    Injury
    Date Received
    January 17, 2026
    Date of Event
    October 31, 2025
    Report Date
    January 17, 2026
    Manufacturer
    NOBEL BIOCARE USA, LLC
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    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
    167709 DZE NOBEL BIOCARE USA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention