BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9611993-2026-060942

    MDR report key: 24644993 · Received March 19, 2026

    Report

    Report Number
    9611993-2026-060942
    Event Type
    Injury
    Date Received
    March 19, 2026
    Date of Event
    November 13, 2025
    Manufacturer
    NOBEL BIOCARE (PRODUCTION) AB
    Product Code
    DZE
    PMA / PMN Number
    K102436
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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
    707369 DZE NOBEL BIOCARE (PRODUCTION) AB

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention