BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZONS INC.

    MDR report key: 23700001 · Received December 2, 2025

    Report

    Report Number
    1060818-2025-37002
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 5, 2025
    Manufacturer
    BIOHORIZONS INC.
    Product Code
    DZE
    UDI-DI
    00847236012472
    PMA / PMN Number
    K223697
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A SCAN BODY (PBTSB; LOT: UNK) IN THIS IMPLANT AND THE SCAN BODY GOT STUCK AND COULD NOT BE REMOVED, CAUSING THE IMPLANT TO HAVE TO BE CUT OUT/REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2782715 BIOHORIZONS INC. DENTAL IMPLANT DZE BIOHORIZONS INC. TIM7010 2500220 00847236012472

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention