BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2027971-2025-113115

    MDR report key: 22767438 · Received August 9, 2025

    Report

    Report Number
    2027971-2025-113115
    Event Type
    Injury
    Date Received
    August 9, 2025
    Report Date
    August 9, 2025
    Manufacturer
    NOBEL BIOCARE USA, LLC
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    RS
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LOSS OF OSSEOINTEGRATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2003693 DZE NOBEL BIOCARE USA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention