BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2027971-2025-101632

    MDR report key: 22513386 · Received July 15, 2025

    Report

    Report Number
    2027971-2025-101632
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    March 15, 2023
    Report Date
    July 15, 2025
    Manufacturer
    NOBEL BIOCARE USA, LLC
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor 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
    545045 DZE NOBEL BIOCARE USA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention