BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL IMPLANT TAPERED INTERNAL

    MDR report key: 23193264 · Received October 1, 2025

    Report

    Report Number
    MW5176804
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Report Date
    September 26, 2025
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS INC.
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE TWO BIO HORIZON DENTAL IMPLANTS THAT WERE IMPLANTED IN 2019. ONE BECAME LOOSE IN (B)(6) 2024 AND THEN IT FELL OUT BECAUSE THE SCREW BROKE. THE SAME IMPLANT FELL OUT AGAIN BECAUSE THE SCREW BROKE AGAIN IN (B)(6) 2025. THE COMPANY SENT A LARGER SCREW, WHICH THE DENTIST HAD TO WORK AROUND AND DRILL MY CROWN TO MAKE ROOM TO REATTACH. AND NOW IN (B)(6) 2025, THE OTHER IMPLANT IS LOOSE AND I EXPECT THE SCREW IS PROBABLY BROKEN AND I AM WAITING ON MY DENTIST APPOINTMENT TO CHECK IT OUT. REFERENCE REPORT: MW5176803.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317870 DENTAL IMPLANT TAPERED INTERNAL IMPLANT, ENDOSSEOUS, ROOT-FORM DZE BIOHORIZONS IMPLANT SYSTEMS INC. TLR4612 1805743

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female