BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZONS INC.

    MDR report key: 23486300 · Received November 6, 2025

    Report

    Report Number
    1060818-2025-35270
    Event Type
    Injury
    Date Received
    November 6, 2025
    Date of Event
    October 8, 2025
    Report Date
    December 3, 2025
    Manufacturer
    BIOHORIZONS INC.
    Product Code
    DZE
    UDI-DI
    00847236010010
    PMA / PMN Number
    K223697
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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
    2688387 BIOHORIZONS INC. DENTAL IMPLANT DZE BIOHORIZONS INC. TLX3412 2404904 00847236010010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention