BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOHORIZONS DENTAL IMPLANT

    MDR report key: 17890845 · Received October 6, 2023

    Report

    Report Number
    1060818-2023-08896
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    June 13, 2023
    Report Date
    July 13, 2023
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS ASSOCIATED WITH REPORT NUMBER 1060818-2023-08887. THIS REPORT WAS DISCOVERED AS A REVIEW OF 1060818-2023-08887.

    Description of Event or Problem · 0

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219381 BIOHORIZONS DENTAL IMPLANT DENTAL IMPLANT DZE BIOHORIZONS IMPLANT SYSTEMS BIOHORIZONS IMPLANT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O