BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZONS INC.

    MDR report key: 23349764 · Received October 21, 2025

    Report

    Report Number
    1060818-2025-34434
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    September 23, 2025
    Report Date
    November 18, 2025
    Manufacturer
    BIOHORIZONS INC.
    Product Code
    DZE
    UDI-DI
    00847236000684
    PMA / PMN Number
    K223697
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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
    841597 BIOHORIZONS INC. DENTAL IMPLANT DZE BIOHORIZONS INC. TSL5807 2101948 00847236000684

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention