BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 4971223 · Received August 5, 2015

    Report

    Report Number
    1030489-2015-01933
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 7, 2015
    Report Date
    July 9, 2015
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8699120, 510K # K981676 WAS CLEARED IN THE UNITED STATES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT PLF AT TH9-L3 LEVELS USING RODS AND PLIF AT UNKNOWN LEVELS FOR TREATING KYPHOSIS. REVISION SURGERY WAS PERFORMED TO EXTEND PLF TO L4-ILIAC WITH RODS AND CONNECT IMPLANTS AT L3 AND L4 WITH DOMINO ON (B)(6) 2012 DUE TO L3/4 VERTEBRAL FRACTURE AND PROGRESSION OF KYPHOSIS. POST-OP, THE PATIENT FELT POPPING AT THE TIME OF LOOKING BACK ON THE CHAIR. THE ROD BREAKAGES ON THE BOTH SIDE (LEFT 5.5MM ROD; RIGHT 4.75MM ROD) WERE CONFIRMED AROUND THE DOMINO CONNECTIONS. ON (B)(6) 2015, THE REVISION SURGERY WAS PERFORMED TO REPLACE THE BROKEN RODS. THE PRODUCTS WERE USED IN THE PATIENT. NO FRAGMENTS OF THE DEVICES WERE REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511629 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention