BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM

    MDR report key: 22309904 · Received June 23, 2025

    Report

    Report Number
    3013450937-2025-00130
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    May 14, 2025
    Report Date
    August 11, 2025
    Manufacturer
    ONKOS SURGICAL INC.
    Product Code
    LPH
    UDI-DI
    B278PVACREC04M0
    PMA / PMN Number
    K212815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORDS WERE REVIEWED FOR PV-ACREC-04M, LOT C24-0238, AND NO MANUFACTURING ABNORMALITIES WERE DISCOVERED. ALL DIMENSIONAL INSPECTIONS WERE WITHIN SPECIFICATION. NONCONFORMANCE HISTORY WAS REVIEWED FOR THIS CASE, AND NO NONCONFORMANCES WERE IDENTIFIED. THE ROOT CAUSE OF THIS EVENT COULD NOT BE IDENTIFIED BASED ON THE AVAILABLE INFORMATION. THE FOLLOWING CORRECTIONS WERE MADE FROM THE INTIAIL MDR SUBMISSION- A1, B2, B3, B4, B5, D1, D2, D4, G3, G6, G4, H2, H6, H10- AS INCORRECT INFORMATION WAS INITIALLY PROVIDED. ALL CONTENT WAS CORRECTED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THIS COMPLAINT WAS NOT DETERMINED. BASED ON THE REVIEW OF KNOWN DEVICE HISTORY RECORDS, THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THE ALLEGED INFECTION WAS NOT RELATED TO THE DESIGN, MANUFACTURE, AND/OR STERILIZATION OF THE REVISED IMPLANTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PELVIC IMPLANT DESIGNED IN CASE(B)(4) WAS UNABLE TO FIT INTO THE PATIENT'S ANATOMY; THEREFORE, AN OFF-THE-SHELF OPTION WAS IMPLANTED INSTEAD. THIS EVENT RESULTED IN APPROXIMATELY 60-MINUTE DELAY. THIS REPORT CAPTURES THE MY3D PERSONALIZED PELVIC RECONTRUCTION IMPLANT. THIS EVENT WILL BE REPORTED TO THE FDA AS A SERIOUS INJURY DUE TO THE 60-MINUTE SURGICAL DELAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT IMPLANTED WITH AN ELEOS DISTAL FEMUR REPLACEMENT WAS REVISED ON (B)(6) 2025 DUE TO AN ALLEGED INFECTION. THIS REPORT CAPTURES THE ELEOS POLY SPACER. THIS EVENT WILL BE REPORTED AS A SERIOUS INJURY DUE TO THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970509 MY3D PERSONALIZED PELVIC RECONSTRUCTION SYSTEM ACETABULAR RECONSTRUCTION IMPLANT LPH ONKOS SURGICAL INC. C25-0238 B278PVACREC04M0

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Other| R