BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,MCOL MG,6.0MM,11MM,MTX

    MDR report key: 25209092 · Received May 18, 2026

    Report

    Report Number
    0001038806-2026-02748
    Event Type
    Injury
    Date Received
    May 18, 2026
    Date of Event
    March 2, 2026
    Report Date
    May 18, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    PMA / PMN Number
    K111889
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. G4: ADDITIONAL PMA/510(K) NUMBER K101880.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT IN SITE 19 WAS REMOVED DUE TO A FRACTURED COLLAR. NOTED INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401274 IMP,TSV,MCOL MG,6.0MM,11MM,MTX DENTAL IMPLANT DZE ZIMVIE US CORP LLC 62533472

    Patients

    Seq Age Sex Outcome Treatment
    1