BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBOCLEAR PEDICLE SCREW SYSTEM

    MDR report key: 11021368 · Received December 16, 2020

    Report

    Report Number
    9615128-2020-00014
    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
    07290110205737
    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 DEVICE WAS NOT AVAILABLE TO THE COMPANY; THUS, ITS PHYSICAL EXAMINATION WAS NOT POSSIBLE.

    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
    1488290 CARBOCLEAR PEDICLE SCREW SYSTEM PEDICLE SCREW REMOVAL TOOL NKB CARBOFIX ORTHOPEDICS LTD. Extractor 73319D 07290110205737

    Patients

    Seq Age Sex Outcome Treatment
    1