BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM

    MDR report key: 21646287 · Received March 19, 2025

    Report

    Report Number
    3013450937-2025-00051
    Event Type
    Injury
    Date Received
    March 19, 2025
    Report Date
    March 19, 2025
    Manufacturer
    ONKOS SURGICAL
    Product Code
    LPH
    PMA / PMN Number
    K212815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH AN ONKOS PELVIC RECONSTRUCTION CASE SUSTAINED A FALL AND FRACTURED A MY3D PERSONALIZED PELVIC RECONSTRUCTION CANCELLOUS BONE SCREW. THE PATIENT WAS REVISED ON 27 FEBRUARY 2025 TO REMOVE THE FRACTURED SCREW COMPONENT. IT IS LIKELY THAT EXTERNAL TRAUMA (I.E. PATIENT FALL) CONTRIBUTED TO THE PATIENT'S CANCELLOUS BONE SCREW FRACTURING. THE MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM IFU WAS REVIEWED, AND THE FOLLOWING RELEVANT POST-OPERATIVE COMPLICATION WAS IDENTIFIED: THE PATIENT IS TO BE WARNED THAT THE DEVICE DOES NOT REPLACE NORMAL HEALTHY BONE, THAT THE IMPLANT CAN BREAK OR BECOME DAMAGED AS A RESULT OF STRENUOUS ACTIVITY, TRAUMA, OR NORMAL USE, AND HAS A FINITE EXPECTED SERVICE LIFE AND MAY NEED TO BE REPLACED AT SOME TIME IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2025, THAT THE PATIENT IMPLANTED WITH ONKOS MY3D PERSONALIZED PELVIC RECONSTRUCTION CASE C24-0458 SUSTAINED A FALL AND FRACTURED A CANCELLOUS BONE SCREW. THE PATIENT WAS REVISED ON (B)(6) 2025 TO REMOVE THE FRACTURED SCREW COMPONENT. THIS EVENT WILL BE REPORTABLE AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688750 MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM CANCELLOUS BONE SCREW LPH ONKOS SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention