BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENOIR POSTERIOR CERVICAL FIXATION SYSTEM

    MDR report key: 23822399 · Received December 16, 2025

    Report

    Report Number
    3009051471-2025-00028
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    November 18, 2025
    Report Date
    January 13, 2026
    Manufacturer
    CTL MEDICAL CORPORATION
    Product Code
    MNI
    PMA / PMN Number
    K121136
    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 3009051471-2025-00027 (INCIDENT INVOLVED TWO DEVICES).

    Additional Manufacturer Narrative · 0

    THIS IS FOLLOW UP 1 TO MDR. SINCE THE INITIAL REPORT, CTL AMEDICA'S ENGINEERING TEAM COMPLETED THE EVALUATION OF THE DEVICE ON 01/05/2026. THE CONCLUSION FROM THE EVALUATION IS THAT THE CAUSE OF THE DEVICE FAILURE WAS FROM MISUSE DURING HANDLING OF THE DEVICE. 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

    WHILE THE SURGEON WAS DRIVING IN THE SCREW, THE HEADBODY CAME OFF OF THE SCREW HEAD. THE SCREW WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158750 RENOIR POSTERIOR CERVICAL FIXATION SYSTEM POLYAXIAL SCREW MNI CTL MEDICAL CORPORATION 012.1524 9HSCF

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown