BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAURUS PEDICLE SCREW SYSTEM

    MDR report key: 23478220 · Received November 5, 2025

    Report

    Report Number
    3009051471-2025-00024
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 24, 2025
    Manufacturer
    CTL MEDICAL CORPORATION
    Product Code
    NKB
    PMA / PMN Number
    K162160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CTL AMEDICA IS CURRENTLY EVALUATING THE DEVICE SUBJECT TO THIS REPORT DUE TO ALL INFORMATION NOT BEING PROVIDED YET TO CTL BY THE REPORTER. A FOLLOW-UP TO THIS REPORT WILL BE SUBMITTED AT THE CONCLUSION OF CTL AMEDICA'S INVESTIGATION. NOTE: THIS REPORT IS RELATED TO REPORT 3009051471-2025-00025 (INCIDENT INVOLVED TWO DEVICES).

    Additional Manufacturer Narrative · 0

    THIS IS FOLLOW UP 1 TO MDR 3009051471-2025-00024. SINCE THE INITIAL REPORT, CTL AMEDICA'S ENGINEERING TEAM COMPLETED THE EVALUATION OF THE DEVICE ON 11/13/2025. COMPLETE SURGICAL DETAILS AND IMAGING FROM ORIGINAL AND REVISION CASES WERE NOT PROVIDED. PRE-REVISION IMAGE SHOWS A SEVERE SCOLIOTIC CURVATURE WITH FULL AND PARTIAL ROD SLIPPAGES. WHEN SPINE REVERTS TOWARD ITS NATURAL CURVATURE, GENERATES FORCES THAT EXCEED THE SET SCREWS CLAMPING FORCES. WITH INCOMPLETE ROD SEATING OR PARTIAL CONTACT, SET SCREW LOOSENING IS EXPECTED. THE ROOT CAUSE IS MOST CONSISTENT WITH THE ROD BEING BENT BY THE SURGEON DURING REVISION TO MATCH THE EXISTING ANATOMICAL CURVE. THE INVESTIGATION FINDINGS AND CONCLUSION CODES IN SECTION H6 HAVE BEEN UPDATED FOR THIS REPORT FROM THE INITIAL REPORT.

    Description of Event or Problem · 0

    THE SURGEON DID A REVISION CASE ON (B)(6) 2025 FOR A PATIENT WHO HAD THE SUBJECT PARTS IMPLANTS ON (B)(6) 2025. THE SUBJECT PARTS HAD TO BE MORVED AS THEY HAD COME OFF THE HOUSING. THE SURGEON REMOVED THE SET SCREWS AND REPLACED THEM ALONG WITH THE RODS (NO ISSUE WITH THE ROD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2607117 TAURUS PEDICLE SCREW SYSTEM SET SCREW NKB CTL MEDICAL CORPORATION 51-0000-000 FCLAC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female