BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6731033 · Received July 21, 2017

    Report

    Report Number
    1030489-2017-01801
    Event Type
    Injury
    Date Received
    July 21, 2017
    Report Date
    June 23, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    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. (B)(4). 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 WAS PREOPERATIVELY DIAGNOSED WITH ADULT SPINAL DEFORMITY AND SPINAL CANAL STENOSIS. SO THE PATIENT UNDERWENT ANTEROLATERAL FUSION AND POSTERIOR INTERBODY FUSION AT LEVELS T8-S2AL. THE MOST CRANIAL SIDE WAS FIXED WITH HOOK AND TLIF SURGERY AT L5-S1 AND OLIF (OBLIQUE LUMBAR INTERBODY FUSION) WERE PERFORMED. POST-OP, IT WAS REPORTED THAT RODS BROKE BETWEEN L5/S. IT IS UNKNOWN IN WHICH OF THE EITHER OR BOTH SIDES. THE PATIENT IS SCHEDULED FOR A REVISION SURGERY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512549 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0298950W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention