BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9611993-2025-103054

    MDR report key: 22486192 · Received July 11, 2025

    Report

    Report Number
    9611993-2025-103054
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    July 2, 2025
    Manufacturer
    NOBEL BIOCARE (PRODUCTION) AB
    Product Code
    DZE
    PMA / PMN Number
    K202344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LACK OF STABILITY DURING PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1728496 DZE NOBEL BIOCARE (PRODUCTION) AB

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention