BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 8MM

    MDR report key: 25171149 · Received May 14, 2026

    Report

    Report Number
    0001038806-2026-02659
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019607
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER CMP (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION K011028/K013227.

    Description of Event or Problem · 0

    THE DOCTOR REPORTS THAT THE MOUNT WAS LOOSE OR UNSCREWED FROM THE IMPLANT, AND THAT UPON OPENING IT, IT FELL OUT OF THE PACKAGING. THE DOCTOR CONFIRMS IN THE FORM THAT THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT, WITH NO NEGATIVE IMPACT ON THE PATIENT¿S HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468146 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 8MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1276045 00889024019607

    Patients

    Seq Age Sex Outcome Treatment
    1