BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN GOLD-TITE LARGE HEXED SCREW

    MDR report key: 25065050 · Received May 4, 2026

    Report

    Report Number
    0001038806-2026-02428
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    August 29, 2024
    Report Date
    May 4, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00844868006121
    PMA / PMN Number
    K972444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. D10. CONCOMITANT MEDICAL PRODUCTS. IUNIHG, CERTAIN GOLD-TITE HEXED SCREW LOT 1280761. ILRGHG, CERTAIN GOLD-TITE LARGE HEXED SCREW LOT 1250285. G4: PREMARKET IDENTIFICATION K072642.

    Description of Event or Problem · 0

    IT WAS REPORTED A FRACTURE OF THREE OF THE PROSTHETIC SCREWS AT THE THREADED PART IN A PATIENT WITH A MANDIBULAR HYBRID PROSTHESIS ON FOUR IMPLANTS (TOOTH SITE 32,34,42,44), SO IT WAS DECIDED TO REPLACE ALL OF THEM, TAKING INTO ACCOUNT THE POSSIBLE OCLUSAL OVERLOAD. PATIENT SUFFERED PROSTHESIS MOBILITY AND INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30925 CERTAIN GOLD-TITE LARGE HEXED SCREW DENTAL SCREW DZE ZIMVIE US CORP LLC 1196425 00844868006121

    Patients

    Seq Age Sex Outcome Treatment
    1