BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP, TSV, 4.7,10,MTX,MC,MG,HA

    MDR report key: 23560073 · Received November 14, 2025

    Report

    Report Number
    0001038806-2025-03169
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    November 4, 2025
    Report Date
    January 26, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024344143
    PMA / PMN Number
    K101880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: ADDITIONAL PMA/510(K) NUMBER K133339.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MOUNT WOULDN'T COME OFF. THE FIXTURE COULD NOT BE REMOVED FROM ITS MOUNT. CLINICIAN SUBSTITUTED IT WITH A DIFFERENT FIXTURE. TOOTH SITE # 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2805351 IMP, TSV, 4.7,10,MTX,MC,MG,HA DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1285762 00889024344143

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female