BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,10,MTX,MG

    MDR report key: 25152508 · Received May 12, 2026

    Report

    Report Number
    0001038806-2026-02610
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    March 10, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019997
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). . G4: ADDITIONAL PMA/510(K) NUMBER ¿ K101880 PRODUCT HAS BEEN RECEIVED BY ZIMVIE AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COPING/MOUNT COULD NOT BE REMOVED DURING IMPLANT PLACEMENT. THE IMPLANT WAS REMOVED AND ANOTHER ONE WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591479 IMP,TSV,4.7,10,MTX,MG DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1302533 00889024019997

    Patients

    Seq Age Sex Outcome Treatment
    1