BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6266011 · Received January 20, 2017

    Report

    Report Number
    1030489-2017-00130
    Event Type
    Malfunction
    Date Received
    January 20, 2017
    Date of Event
    December 26, 2016
    Report Date
    December 26, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT (OPLL) AND OSSIFICATION OF THE YELLOW LIGAMENT (OYL) PROCEDURE: POSTERIOR THORACIC DECOMPRESSION FUSION LEVELS OF IMPLANT: TH1-TH12 IT WAS REPORTED THAT DURING SURGERY, A SET SCREW COULD NOT BE BROKEN OFF. THERE WAS NO SPACE BETWEEN THE ROD AND THE CROSSLINK AND IT WAS CLOSED SO THAT THE SET SCREW COULD GET IN. THE SURGEON PLACED THE CROSSLINK AND BROKE OFF A SET SCREW ON ONE SIDE. WHEN THE SURGEON TRIED TO BREAK OFF A SET SCREW ON THE OTHER SIDE, TORQUE COULD NOT BE APPLIED TO THE SET SCREW AND THE SET SCREW GOT INTO THE THREAD OF SCREW. THE SURGEON REMOVED THE SCREW USING REMOVAL SCREW DRIVER AND TRIED IT AGAIN WITH A NEW SCREW BUT SAME EVENT OCCURRED. THE SURGEON ATTEMPTED TO REMOVE THE SETSCREW THAT WAS SUCCESSFULLY BROKEN OFF FIRST USING REMOVAL SCREW DRIVER BUT IT WAS DIFFICULT TO REMOVE BECAUSE THE DRIVER STRIPPED. THE SURGEON JUDGED THAT IT DID NOT NEED TO BE REMOVED BECAUSE IT WAS TIGHTLY TIGHTENED, AND THE SCREW ON THE OTHER SIDE REMAINED IN THE PATIENT¿S BODY WITHOUT BREAKING OFF. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51627 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0344915W

    Patients

    Seq Age Sex Outcome Treatment
    1