BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9611993-2026-052565

    MDR report key: 24435969 · Received February 24, 2026

    Report

    Report Number
    9611993-2026-052565
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    October 22, 2025
    Manufacturer
    NOBEL BIOCARE (PRODUCTION) AB
    Product Code
    DZE
    PMA / PMN Number
    K071370
    Adverse Event
    Yes
    Report Source
    Manufacturer 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
    499575 DZE NOBEL BIOCARE (PRODUCTION) AB

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention