BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10268100 · Received July 13, 2020

    Report

    Report Number
    1030489-2020-00888
    Event Type
    Injury
    Date Received
    July 13, 2020
    Report Date
    July 14, 2020
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR SPINAL CANAL STENOSIS FOR POSTERIOR LUMBAR FUSION (PLF) FUSION THERAPY. IT WAS REPORTED THAT L4/5 ADJACENT SEGMENT DISEASE AFTER L3/4 PLF FIXATION OCCURRED. RE OPERATION WAS SCHEDULED FOR JUNE, 23. PS WILL BE ADDED AT L5, DECOMPRESSION AND PLF WILL BE PERFORMED AT L4/5 IF BONE FUSION IS ACHIEVED AFTER OPENING THE PATIENT. THERE WERE PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PARALYSIS ON THE LATERAL SIDE OF THE RIGHT THIGH AND THE LOWER MEDIAL SIDE OF THE RIGHT KNEE, LEADING TO RE OPERATION. AS TO THE PATIENT'S CONDITION AFTER THE RE OPERATION, POSTOPERATIVE LEG MOVEMENT WAS ALSO GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726509 CD HORIZON SPINAL SYSTEM KWQ MEDTRONIC SOFAMOR DANEK USA, INC MSB_UK_SOLERA 4.75 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention