BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9552346 · Received January 6, 2020

    Report

    Report Number
    1030489-2020-00024
    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

    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.

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

    Description of Event or Problem · 1

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

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13712 CD HORIZON SPINAL SYSTEM KWP WARSAW ORTHOPEDICS NA 0441699W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention