BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SOLERA SPINAL SYSTEM

    MDR report key: 7062550 · Received November 28, 2017

    Report

    Report Number
    1030489-2017-02399
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Date of Event
    November 1, 2017
    Report Date
    April 20, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 6430530, 510K# K143375 AND (B)(4) IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: VISUAL AND MICROSCOPIC EXAMINATION REVEALED THREAD CREST AND FLANK DAMAGE; THIS DAMAGE APPEARS TO HAVE INITIATED AT THE START OF THE THREAD AND IS CONSISTENT AROUND THE DAMAGED PORTION OF THE THREADS. THIS IS CONSISTENT WITH MISALIGNMENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED WITH VERTEBRAL FRACTURE AT T7/8/9, UNDERWENT PERCUTANEOUS POSTERIOR FUSION WITH TWO LEVELS ABOVE AND TWO LEVELS BELOW. DURING SURGERY, AT THE TIME OF FINAL TIGHTENING AT T11 ON THE LEFT SIDE, THE SET SCREW WAS SPINNING AND COULD NOT BE BROKEN OFF. THE COUNTER WAS REINSERTED TO PERFORM FINAL TIGHTENING BUT IT FAILED. THE CONCERNED SET SCREW WAS BROKEN PARTLY AND HENCE WAS EXCHANGED WITH NEW ONE. THERE WAS NO PROBLEM WITH THE PROCEDURE. BROKEN FRAGMENTS WERE NOT CONFIRMED IN X-RAY OF 1 WEEK AFTER THE OPERATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844036 CD HORIZON SOLERA SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0580188W

    Patients

    Seq Age Sex Outcome Treatment
    1