BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8969215 · Received September 6, 2019

    Report

    Report Number
    1030489-2019-00991
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Report Date
    September 6, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    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#: 55811014540, 510K#: K122433 AND UDI #: (B)(4) 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A SURGERY AT L1-L4. ON (B)(6) 2019, SCREW REMOVAL SURGERY WAS BEING PERFORMED AS THE FUSION WAS ACHIEVED. BEFORE STARTING THE SURGERY, A PRE OPERATIVE CT WAS PERFORMED, WHICH SHOWED THAT THE SCREW AT RIGHT SIDE OF L4 WAS BROKEN. DURING SCREW REMOVAL SURGERY, THE BROKEN SCREW COULD NOT BE COMPLETELY REMOVED AS THE PEDICLE WAS NARROW AND THERE WAS A HIGH RISK IN REMOVING THE SCREW. HENCE, ONLY THE HEAD PART OF THE SCREW WAS REMOVED WHILE THE TIP PART OF THE SCREW REMAINED INSIDE THE PATIENT'S BODY. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764410 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK USA, INC NA CA14C099

    Patients

    Seq Age Sex Outcome Treatment
    1