BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10360681 · Received August 4, 2020

    Report

    Report Number
    1030489-2020-01025
    Event Type
    Injury
    Date Received
    August 4, 2020
    Report Date
    August 4, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    510(K) NO. IS K981676 FOR PARENT ITEM. DEVICE EVALUATION NOT POSSIBLE AS IT REMAINS IMPLANTED IN PATIENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF LUMBAR SPINAL CANAL STENOSIS. THERE WERE PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ADJACENT SEGMENT DISEASE OCCURRED ON L3/4. ADJACENT SEGMENT DISEASE OCCURRED ON L3/4. OLIF WAS PERFORMED ON L3/4, POSTERIOR PPS WAS PLANNED. RE-OPERATION WAS COMPLETED ON JULY, 17. THERE WAS NO MALFUNCTION OF THE IMPLANTED PRODUCT. BONE FUSION HAS BEEN ACHIEVED BETWEEN L4/5, THE SCREW ON L5 WAS REMOVED, OLIF ON L3/4 AND POSTERIOR FIXATION WERE PERFORMED AND THE PROCEDURE WAS COMPLETED. IMMEDIATELY AFTER THE OPERATION, THERE WAS NO PROBLEM WITH THE MOVEMENT OF THE LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827165 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS G8699050 0051822W

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention