BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM

    MDR report key: 25152679 · Received May 12, 2026

    Report

    Report Number
    0001038806-2026-02613
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024020085
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    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 IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. TOOTH SITE # 26.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182638 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM Implant, endosseous, root-form DZE ZIMVIE US CORP LLC 1276935 00889024020085

    Patients

    Seq Age Sex Outcome Treatment
    1