BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2027971-2026-081286

    MDR report key: 25235415 · Received May 20, 2026

    Report

    Report Number
    2027971-2026-081286
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    March 26, 2026
    Report Date
    May 20, 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

    LOSS OF OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94405 DZE NOBEL BIOCARE USA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Female Required Intervention