BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® TITANIUM LARGE HEXED SCREW

    MDR report key: 25134569 · Received May 11, 2026

    Report

    Report Number
    0001038806-2026-02581
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 5, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00844868006138
    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 . ILRGHT, CERTAIN® TITANIUM LARGE HEXED SCREW LOT 1273390. G4: PREMARKET IDENTIFICATION K072642.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREWS FRACTURED. OTHER SCREWS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301460 CERTAIN® TITANIUM LARGE HEXED SCREW DENTAL SCREW DZE ZIMVIE US CORP LLC 1273390 00844868006138

    Patients

    Seq Age Sex Outcome Treatment
    1