BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM

    MDR report key: 23067640 · Received September 16, 2025

    Report

    Report Number
    3013450937-2025-00221
    Event Type
    Injury
    Date Received
    September 16, 2025
    Report Date
    September 16, 2025
    Manufacturer
    ONKOS SURGICAL
    Product Code
    LPH
    PMA / PMN Number
    K212815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH MY3D PELVIS CASE C25-0222 HAD AN ALLEGED INFECTION. THE PATIENT RECEIVED A WASHOUT PROCEDURE- NO DEVICES WERE EXPLANTED DURING THIS PROCEDURE.THE ROOT CAUSE OF THE PATIENT'S ALLEGED INFECTION COULD NOT BE DETERMINED BASED ON AVAILABLE INFORMATION. THE FOLLOWING MDR SUBMISSIONS ARE A PART OF THIS EVENT: 3013450937-2025-00174, 3013450937-2025-00216, 3013450937-2025-00217, 3013450937-2025-00218, 3013450937-2025-00219, 3013450937-2025-00220, 3013450937-2025-00222, 3013450937-2025-00223, 3013450937-2025-00224, 3013450937-2025-00225, 3013450937-2025-00226, 3013450937-2025-00227, 3013450937-2025-00228.

    Description of Event or Problem · 0

    ON (B)(6) 2025 : THE PATIENT IMPLANTED WITH MY3D PELVIC RECONSTRUCTION SYSTEM CASE (B)(4) HAD AN ALLEGED INFECTION. THE PATIENT RECEIVED A WASHOUT PROCEDURE- NO DEVICES WERE EXPLANTED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2681399 MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM CANCELLOUS BONE SCREW LPH ONKOS SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention