BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBOCLEAR PEDICLE SCREW SYSTEM

    MDR report key: 10167005 · Received June 18, 2020

    Report

    Report Number
    9615128-2020-00007
    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
    07290110205744
    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 BENDING FRACTURE AT THE MID SHAFT IN ITS SLOTTED AREA. IT IS NOTED, THAT THE USE OF THE DEVICE IN VERY HARD BONE (AS IN THE INVOLVED CASE) MAY HAVE CONTRIBUTED TO THE REPORTED FAULT. NEVERTHELESS, THE COMPANY HAS DECIDED TO IMPROVE THE DEVICE IN ORDER TO MINIMIZE PROBABILITY OF RECURRENCE.

    Description of Event or Problem · 1

    DURING A SURGERY WITH THE CARBOCLEAR PEDICLE SCREW SYSTEM, FOR THE TREATMENT OF ONCOLOGICAL PATIENT, A SCREW REMOVAL TOOL BROKE WHILE TRYING TO REMOVE THE DISTAL PART OF A BROKEN SCREW. THE SURGEON USED ANOTHER TOOL TO RETRIEVE THE SCREW AND SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634420 CARBOCLEAR PEDICLE SCREW SYSTEM PEDICLE SCREW REMOVAL TOOL NKB CARBOFIX ORTHOPEDICS LTD. Extractor 73320 07290110205744

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR