BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,MCOL MG,4.7MM,10M

    MDR report key: 25221858 · Received May 19, 2026

    Report

    Report Number
    0001038806-2026-02794
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Report Date
    May 19, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019775
    PMA / PMN Number
    K111889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). . G4: ADDITIONAL PMA/510(K) NUMBER K101880.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #UNK WAS NOT PLACED AS THE PACKAGING WAS NOT SEALED PROPERLY. PACKAGE IS NOT PROPERLY SEALED. THE OUTER PART OF THE PACKAGING IS NOT SEALED PROPERLY (THE LEAD IS NOT TIGHTLY CLOSED AND THE LOCK (THE NOTCHES ON THE BOX) APPEARS TO HAVE BEEN DEFECTIVE. I DISCOVERED IT TODAY DURING IMPLANT PLACEMENT. I DO NOT FEEL COMFORTABLE PLACING THIS IMPLANT AS NOT ALL PACKAGING IS INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9695 IMP,TSV,MCOL MG,4.7MM,10M DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1260265 00889024019775

    Patients

    Seq Age Sex Outcome Treatment
    1