BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAIN® TITANIUM LARGE HEXED SCREW

    MDR report key: 24581470 · Received March 12, 2026

    Report

    Report Number
    0001038806-2026-01329
    Event Type
    Malfunction
    Date Received
    March 12, 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
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). D10: CONCOMITANT MEDICAL PRODUCT: IUNIHT, CERTAIN® TITANIUM HEXED SCREW, LOT: 1258670. G4: PREMARKET IDENTIFICATION PMA/510(K) #: K072642.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCREWS WERE LOOSENED AND DID NOT HOLD THE CROWNS PROPERLY, AND THE SCREWS WERE REMOVED. NO OTHER SCREWS WERE USED IN EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571582 CERTAIN® TITANIUM LARGE HEXED SCREW DENTAL SCREW DZE ZIMVIE US CORP LLC 1299289 00844868006138

    Patients

    Seq Age Sex Outcome Treatment
    1