BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZONS INC.

    MDR report key: 19770264 · Received July 18, 2024

    Report

    Report Number
    1060818-2024-09823
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    June 26, 2024
    Report Date
    November 16, 2024
    Manufacturer
    BIOHORIZONS INC.
    Product Code
    DZE
    UDI-DI
    00847236009786
    PMA / PMN Number
    K223697
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FTI.

    Description of Event or Problem · 0

    FTI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145027 BIOHORIZONS INC. DENTAL IMPLANT DZE BIOHORIZONS INC. TLX3010 2302220 00847236009786

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention