BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZONS INC.

    MDR report key: 23299410 · Received October 15, 2025

    Report

    Report Number
    1060818-2025-33985
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 16, 2025
    Report Date
    November 11, 2025
    Manufacturer
    BIOHORIZONS INC.
    Product Code
    DZE
    UDI-DI
    00847236013769
    PMA / PMN Number
    K223697
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Description of Event or Problem · 0

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021331 BIOHORIZONS INC. DENTAL IMPLANT DZE BIOHORIZONS INC. BTA4610 2500835 00847236013769

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention