BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPASSIONATE USE DEVICE

    MDR report key: 10825217 · Received November 11, 2020

    Report

    Report Number
    1724955-2020-00005
    Event Type
    Injury
    Date Received
    November 11, 2020
    Date of Event
    September 21, 2020
    Report Date
    November 10, 2020
    Manufacturer
    3D SYSTEMS
    Product Code
    PBF
    PMA / PMN Number
    U200183
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S TIBIA BECAME INFECTED AFTER THE ALLOGRAFT RECONSTRUCTION PROCEDURE AND A SURGICAL INTERVENTION TO REMOVE THE PATIENT'S ALLOGRAFT WAS SUCCESSFUL. 3D SYSTEMS PROVIDED A COMPASSIONATE USE DEVICE PATIENT TIBIA CUTTING GUIDE AND A COMPASSIONATE USE DEVICE ALLOGRAFT TIBIA CUTTING GUIDE FOR THE INITIAL PROCEDURE (TUMOR RESECTION AND ALLOGRAFT RECONSTRUCTION) THROUGH THE FDA EXPANDED ACCESS PATHWAY (U200183). UPON INVESTIGATION, THERE WERE NO IDENTIFIED FAILURE MODES IN THE DESIGN OR MANUFACTURING OF THE DEVICE, NOR ANY REPORTED MALFUNCTIONS OF DEVICE DURING ITS USE. ALL INSTRUCTIONS PROVIDED IN THE IFU WERE STATED TO BE FOLLOWED PRIOR TO AND DURING THE USE OF THE DEVICE. THE PATIENT WILL UNDERGO ADDITIONAL SURGERY AT A LATER DATE TO IMPLANT A NEW ALLOGRAFT TIBIA.

    Description of Event or Problem · 1

    THE PATIENT'S TIBIA BECAME INFECTED AFTER THE ALLOGRAFT RECONSTRUCTION PROCEDURE AND A SURGICAL INTERVENTION TO REMOVE THE PATIENT'S ALLOGRAFT WAS SUCCESSFUL. 3D SYSTEMS PROVIDED A COMPASSIONATE USE DEVICE PATIENT TIBIA CUTTING GUIDE AND A COMPASSIONATE USE DEVICE ALLOGRAFT TIBIA CUTTING GUIDE FOR THE INITIAL PROCEDURE (TUMOR RESECTION AND ALLOGRAFT RECONSTRUCTION) THROUGH THE FDA EXPANDED ACCESS PATHWAY (U200183). UPON INVESTIGATION, THERE WERE NO IDENTIFIED FAILURE MODES IN THE DESIGN OR MANUFACTURING OF THE DEVICE, NOR ANY REPORTED MALFUNCTIONS OF DEVICE DURING ITS USE. ALL INSTRUCTIONS PROVIDED IN THE IFU WERE STATED TO BE FOLLOWED PRIOR TO AND DURING THE USE OF THE DEVICE. THE PATIENT WILL UNDERGO ADDITIONAL SURGERY AT A LATER DATE TO IMPLANT A NEW ALLOGRAFT TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291862 COMPASSIONATE USE DEVICE TIBIA CUTTING GUIDE PBF 3D SYSTEMS 135765

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention