BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBOCLEAR PEDICLE SCREW SYSTEM

    MDR report key: 10166994 · Received June 18, 2020

    Report

    Report Number
    9615128-2020-00003
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 20, 2020
    Report Date
    June 18, 2020
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    NKB
    UDI-DI
    07290110200640
    PMA / PMN Number
    K173487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE PRODUCTION RECORDS OF THE INVOLVED ITEM INDICATED IT WAS MANUFACTURED ACCORDING TO SPECIFICATION. THE INVOLVED ITEM WAS RECEIVED AND UNDERWENT AN EXAMINATION. THE VISUAL EXAMINATION (UNDER A MICROSCOPE) REVEALED BREAKAGE IN THE MIDDLE OF THE SCREW SHAFT. IN ADDITION, THE SCREW WAS CUT LONGITUDINALLY AND MATERIAL INTEGRITY WAS FOUND IN ORDER. IT IS NOTED, THAT THE DISCUSSED CASE INVOLVED POST-RADIATION HARD VERTEBRAL BONE, AND THAT TAPPING WAS PERFORMED USING A 5MM DIAMETER BONE TAP (PRIOR TO 5.5MM DIAMETER SCREW INSERTION).

    Description of Event or Problem · 1

    DURING A SURGERY WITH THE CARBOCLEAR PEDICLE SCREW SYSTEM, FOR THE TREATMENT OF ONCOLOGICAL PATIENT, A SCREW BROKE WHILE BEING INSERTED INTO THE PEDICLE; THE SCREW WAS REMOVED AND SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634090 CARBOCLEAR PEDICLE SCREW SYSTEM PEDICLE SCREW NKB CARBOFIX ORTHOPEDICS LTD. Pedicle Screw - Non Cannulated 77210 07290110200640

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR