BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 25260407 · Received May 22, 2026

    Report

    Report Number
    0001038806-2026-02853
    Event Type
    Injury
    Date Received
    May 22, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    PMA / PMN Number
    K111889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER: (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. B3: DATE OF EVENT UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER K101880.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 WAS REMOVED DUE TO BONE LOSS. BONE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160585 IMP,TSV,MCOL MG,4.7MM,10M DENTAL IMPLANT DZE ZIMVIE US CORP LLC 62947801

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention