BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTRON S.P.A

    MDR report key: 25039564 · Received April 30, 2026

    Report

    Report Number
    3003933619-2026-70001
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    April 15, 2026
    Report Date
    April 29, 2026
    Manufacturer
    MECTRON S.P.A.
    Product Code
    DZI
    UDI-DI
    0322036000130
    PMA / PMN Number
    K153743
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION ABOUT SURGERY AND PATIENT STATE OF HEALTH OTHER THAN THE RETURN OF THE INVOLVED DEVICES WERE REQUESTED TO THE HEALTHCARE FACILITY.

    Description of Event or Problem · 0

    DURING A MANDIBULAR CONTOURING CASE FOR A FACIAL FEMINIZATION PATIENT, THE SUBMENTAL ARTERY AND UNDERLINED SOFT TISSUE WERE DAMAGED. THE GOAL OF THE PROCEDURE WAS TO REDUCE THE PATIENT'S MANDIBULAR ANGLES IN ADDITION TO REDUCTIONS OF THE LATERAL WALLS OF THE ENTIRE MANDIBLE, AS WELL AS A GENIOPLASTY. THE DEVICES USED FOR SURGERY WERE PIEZOSURGERY PLUS, PIEZOSURGERY MEDICAL + HANDIPIECE AND INSERT MT8-20 L. THE DOCTOR ADMINISTRARED HEMOSTATIC AGENTS TO CONTROL BLEEDING AND ACHIEVE COAGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260477 MECTRON S.P.A SINGLE USE INSERT FOR BONE SURGERY DZI MECTRON S.P.A. MT8- 20 L 25001982 0322036000130

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention