BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 7471736 · Received April 30, 2018

    Report

    Report Number
    1030489-2018-00628
    Event Type
    Injury
    Date Received
    April 30, 2018
    Report Date
    December 3, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 778116565 , 510K# K090390 AND UDI (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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS RESULT: THE CONNECTOR HAS A WEAR MARK INSIDE OF THE ROD SLOT FROM THE ROD MOVING BACK IN FOURTH. THE THREADS DO NOT APPEAR TO BE DAMAGED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT EXTENSION OF FUSION TO TH3 FROM TH8-S2AI. POST-OP, PAIN WAS OBSERVED DUE TO BACKING OUT OF CONNECTOR. VERTEBRAL BODY FRACTURE OCCURRED AT T3 OF THE MOST CRANIAL SIDE, AND HENCE THE FUSION FOR EXTENDING TO C7 WAS PERFORMED. BECAUSE CONNECTORS ON THE BOTH SIDES WERE SHAVED AND THE ROD WAS NOT FIXED, THEY BACKED OUT EASILY. THE PHYSICIAN JUDGED THAT THE ROD CAME OFF BECAUSE THE CONNECTOR MOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316734 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0451961W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention