BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5187216 · Received October 29, 2015

    Report

    Report Number
    1030489-2015-02860
    Event Type
    Injury
    Date Received
    October 29, 2015
    Report Date
    October 14, 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 # 1556000500, 510K # K111942 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 A PATIENT UNDERWENT PLF SURGERY AT TH10-S LEVELS FOR KYPHOSCOLIOSIS (HOOK OF IMPLANT AT RIGHT TH10, L3 SKIP, PEDICLE SCREW AT OTHER LEVELS, L3 OSTEOTOMY). ON UNKNOWN DATE, THE BOTH RODS WERE BROKEN AROUND L3 LEVEL. THE REVISION SURGERY TO REPLACE RODS WAS SCHEDULED ON (B)(6) 2015. THE LEVELS AT WHICH THE SET SCREW GOT STUCK IS RIGHT L3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717877 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention