BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9552396 · Received January 6, 2020

    Report

    Report Number
    1030489-2020-00025
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Report Date
    April 27, 2020
    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 USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 1556200500, 510K #K131321 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE R EPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    X-RAY IMAGE REVIEW RESULT: AP AND LATERAL IMAGE WAS PROVIDED FOR LONG SEGMENT THORACO-LUMBAR PELVIC FIXATION. MULTIPLE INTERBODY GRAFTS ARE PRESENT. THE RODS ARE FRACTURED ON BOTH SIDES AT THE SAME LEVEL. THIS IS A TRANSITION ZONE IN THE UPPER LUMBAR SPINE. THE OVERALL ROD CONTOUR IS FLAT. FUSION STATUS IS UNKNOWN. ADDITIONAL INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A SURGERY AT T6-S2AI DUE TO LUMBAR DEGENERATIVE KYPHOSIS. SCREWS AND RODS WERE IMPLANTED DURING THIS SURGERY. ON AN UNKNOWN DATE, POST-OP, ROD BREAKAGE OCCURRED. HENCE, PATIENT UNDERWENT A REVISION SURGERY, IN WHICH ROD CONNECTION AND REINFORCEMENT WAS PERFORMED.

    Description of Event or Problem · 1

    CURRENTLY, THERE HAVE BEEN NO PATIENT COMPLICATIONS REPORTED IN PARTICULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15978 CD HORIZON SPINAL SYSTEM KWP WARSAW ORTHOPEDICS NA 0441699W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention