BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBOCLEAR PEDICLE SCREW SYSTEM

    MDR report key: 11021333 · Received December 16, 2020

    Report

    Report Number
    9615128-2020-00013
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    November 6, 2020
    Report Date
    December 16, 2020
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    NKB
    UDI-DI
    07290110204372
    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 IMPLANT WAS NOT AVAILABLE TO THE COMPANY;THUS, ITS PHYSICAL EXAMINATION WAS NOT POSSIBLE. ACCORDING TO INFORMATION PROVIDED TO THE COMPANY BY THE SURGEON, IN ORDER TO ADJUST SCREW TULIP, LATERAL FORCES WERE ALLIED ON THE SCREW WHILE IT WAS HALF WAY INSERTED INTO THE PEDICLE. THIS RESULTED IN SCREW BREAKAGE.

    Description of Event or Problem · 1

    DURING A SURGERY WITH THE CARBOCLEAR PEDICLE SCREW SYSTEM, FOR THE TREATMENT OF AN ONCOLOGICAL PATIENT, A SCREW WAS INSERTED ONLY HALF WAY INTO THE L5 PEDICLE DUE TO PATIENT ANATOMY AND THE NEED TO CONNECT TO S1 VERTEBRA. WHEN THE SURGEON TRIED TO ADJUST THE TULIP, THE SCREW BROKE. THE SCREW WAS REMOVED, AND ANOTHER SCREW WAS USED. THE SURGERY WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1487371 CARBOCLEAR PEDICLE SCREW SYSTEM PEDICLE SCREW NKB CARBOFIX ORTHOPEDICS LTD. Template 77214 07290110204372

    Patients

    Seq Age Sex Outcome Treatment
    1