BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2027971-2024-103722

    MDR report key: 19782898 · Received July 19, 2024

    Report

    Report Number
    2027971-2024-103722
    Event Type
    Injury
    Date Received
    July 19, 2024
    Date of Event
    July 8, 2024
    Manufacturer
    NOBEL BIOCARE USA, LLC
    Product Code
    DZE
    PMA / PMN Number
    K023113
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1978610 DZE NOBEL BIOCARE USA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention