BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9611993-2024-133157

    MDR report key: 20813443 · Received November 29, 2024

    Report

    Report Number
    9611993-2024-133157
    Event Type
    Injury
    Date Received
    November 29, 2024
    Date of Event
    November 26, 2024
    Manufacturer
    NOBEL BIOCARE (PRODUCTION) AB
    Product Code
    DZE
    PMA / PMN Number
    K173418
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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
    332688 DZE NOBEL BIOCARE (PRODUCTION) AB

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention