BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPHAEL

    MDR report key: 19582059 · Received June 21, 2024

    Report

    Report Number
    3009051471-2024-00006
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    November 8, 2023
    Report Date
    June 19, 2024
    Manufacturer
    CTL MEDICAL CORPORATION
    Product Code
    MNI
    PMA / PMN Number
    K132365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CAUSE OF THE FAILURE IS A NON-DEVICE RELATED FACTOR SUCH AS ADVERSE EVENTS RELATED TO THE PATIENT'S CONDITION. THE OBSERVED IMPLANT FAILURE(S), HOWEVER, CAN RESULT FROM EXCESSIVE LOADING AND/OR THE ABSENCE OF FUSION WITHIN SIX MONTHS POST-SURGERY.

    Description of Event or Problem · 0

    ON (B)(6) 2020, INITIAL L4, L5, S1 LEFT & L5,S1 RIGHT INSTRUMENTATION SURGERY WAS PERFORMED. ON (B)(6) 2023, REVISION L4, L5, S1 LEFT & L4,L5,S1 RIGHT INSTRUMENTATION EXTENSION SURGERY WAS PERFORMED AFTER THE REMOVAL OF BROKEN S1 SCREWS. PRE- OR POST-OP X-RAY ETC., WERE NOT PROVIDED. ALL REMOVED COMPONENTS WERE NOT RETURNED FOR EVALUATION. S1 SCREWS WERE BROKEN IN THE MIDDLE REGION OF THE SCREW SHAFT. NO HARM OR INJURY TO THE PATIENT WAS REPORTED BEFORE OR AFTER THE SURGERY. THE LAST SURGERY'S DOCTOR'S OPERATIVE REPORTS WERE PROVIDED. THE CAUSE IS PSEUDOARTHROSIS ( A CONDITION WHEN BONES FAIL TO FUSE WITH ONE ANOTHER DUE TO THE PATIENT'S REDUCED ABILITY TO GENERATE BONE-PRODUCING CELLS (CALLED OSTEOBLASTS) NEEDED FOR FUSION.) THIS IS A NON-DEVICE RELATED FACTORS SUCH AS ADVERSE EVENTS RELATED TO PATIENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115906 RAPHAEL PEDICLE SCREW, 7.5 X L45MM MNI CTL MEDICAL CORPORATION 015.3447 9L4DD

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female