BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAIN® TITANIUM LARGE HEXED SCREW

    MDR report key: 25161180 · Received May 13, 2026

    Report

    Report Number
    0001038806-2026-02638
    Event Type
    Injury
    Date Received
    May 13, 2026
    Date of Event
    March 30, 2026
    Report Date
    May 13, 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). A1: PATIENT IDENTIFIER: UNKNOWN / NOT PROVIDED. A2: AGE AT TIME OF THE EVENT: UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT: UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION PMA/510(K) #: K072642.

    Description of Event or Problem · 0

    IT WAS REPORTED SCREW LOOSENING, IMPOSSIBLE TO APPLY TORQUE. NEW SCREW WOULD BE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483059 CERTAIN® TITANIUM LARGE HEXED SCREW DENTAL SCREW DZE ZIMVIE US CORP LLC 1299289 00844868006138

    Patients

    Seq Age Sex Outcome Treatment
    1