BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM

    MDR report key: 24871333 · Received April 14, 2026

    Report

    Report Number
    0001038806-2026-02026
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    December 17, 2025
    Report Date
    May 14, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 K011028, K013227.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED AS IT WAS FRACTURED. IMPLANT FRACTURED NEEDED TO COME OUT, PATIENT THINKING ABOUT REPLACING WITH NEW IMPLANT IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172204 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 13MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 61051574

    Patients

    Seq Age Sex Outcome Treatment
    1