BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MY3D PELVIC RECONSTRUCTION SYSTEM

    MDR report key: 21998451 · Received May 9, 2025

    Report

    Report Number
    3013450937-2025-00097
    Event Type
    Injury
    Date Received
    May 9, 2025
    Date of Event
    April 9, 2025
    Report Date
    August 11, 2025
    Manufacturer
    ONKOS SURGICAL
    Product Code
    LPH
    UDI-DI
    B278PVACREC04M0
    PMA / PMN Number
    K212815
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE FOR THE PATIENT SPECIFIC CASE, THE SURGEON WAS UNABLE TO USE THE IMPLANT. THE PROCEDURE WAS INITIALLY SCHEDULED FOR (B)(6) 2024; HOWEVER, THE PATIENT BECAME INFECTED AND REQUIRED ADDITIONAL TIME TO CLEAR THE INFECTION. THE SURGERY WAS RESCHEDULED TO (B)(6) 2025. THE SURGEON WAS NOT ABLE TO GET THE IMPLANT TO FIT WITH PATIENT ANATOMY INTRAOPERATIVELY. THE SURGEON SWITCHED TO AN OFF THE SHELF LARGE MULTI-HOLE CUP. THE DELAY IN COMPLETING THE SURGERY WAS SAID TO BE INSIGNIFICANT, LESS THAN 30 MINUTES. DEVICE HISTORY RECORDS WERE REVIEWED FOR PV-ACREC-04M, LOT C24-0701, AND NO MANUFACTURING ABNORMALITIES WERE DISCOVERED. ALL DIMENSIONAL INSPECTIONS WERE WITHIN SPECIFICATION. THE ROOT CAUSE OF THIS EVENT COULD NOT BE IDENTIFIED BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS DIFFICULTY IMPLANTING AN ONKOS PELVIC RECONSTRUCTION IMPLANT, RESULTING IN THE SURGEON USING AN ALTERNATE PELVIC IMPLANT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ALTERNATE DEVICE. THIS EVENT WILL BE REPORTED TO THE FDA AS A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968220 MY3D PELVIC RECONSTRUCTION SYSTEM ACETABULAR RECONSTRUCTION IMPLANT LPH ONKOS SURGICAL C24-0701 B278PVACREC04M0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other