BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBOCLEAR PEDICLE SCREW SYSTEM

    MDR report key: 8284556 · Received January 29, 2019

    Report

    Report Number
    9615128-2019-00001
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    November 7, 2018
    Report Date
    January 29, 2019
    Manufacturer
    CARBOFIX ORTHOPEDICS LTD.
    Product Code
    NKB
    UDI-DI
    17290110200685
    PMA / PMN Number
    K173487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FUNCTIONAL TEST WAS PERFORMED ON THE DISASSEMBLED SCREW (AFTER RE-ASSEMBLING IT). TEST INCLUDED PEDICLE SCREW INSERTION INTO A BONE MODEL (RIGID POLYURETHANE FOAM) USING CARBOCLEAR SCREWDRIVER (FOLLOWING PROPER TAPPING). SCREW WAS SUCCESSFULLY INSERTED AND LOCKED. IN ADDITION, SCREW POLYAXIALITY WAS EXAMINED AND FOUND IN ORDER. (TESTING OF THE SECOND SCREW, WHICH WAS DAMAGED DURING ITS EXTRACTION, WAS NOT FEASIBLE). EXAMINATION OF THE PRODUCTION RECORDS OF THE INVOLVED ITEMS INDICATED THEY WERE MANUFACTURED ACCORDING TO SPECIFICATION. ACCORDING TO THE COMPLAINT DESCRIPTION, IT IS POSSIBLE THAT THE PEDICLE SCREWS WERE NOT TIGHTLY CONNECTED TO THE SCREWDRIVER PRIOR TO THEIR INSERTION (AS INSTRUCTED IN THE SYSTEM SURGICAL TECHNIQUE).

    Description of Event or Problem · 1

    DURING A SURGERY IN (B)(6), TWO PEDICLE SCREWS DISASSEMBLED WHILE BEING INSERTED TO L1 VERTEBRA. SCREWS WERE REMOVED AND ANOTHER SCREW WAS USED. (DATE OF EVENT IS ESTIMATED ACCORDING TO THE INFORMATION PROVIDED IN THE COMPLAINT REPORT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80087 CARBOCLEAR PEDICLE SCREW SYSTEM PEDICLE SCREW NKB CARBOFIX ORTHOPEDICS LTD. 75576A 17290110200685

    Patients

    Seq Age Sex Outcome Treatment
    1