BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 14100100 · Received April 13, 2022

    Report

    Report Number
    1030489-2022-00347
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 15, 2022
    Report Date
    April 13, 2022
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 55811015540, 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 · 0

    INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING POST-OP OF THE REPORTED PRODUCT. PATIENT MEDICAL HISTORY INCLUDES AIS. IT WAS REPORTED THAT, WHEN THE SCREWS WERE CHECKED AFTER THE SURGERY, THEY WERE DEVIATED. THE PATIENT ALSO DEVELOPED NEUROLOGICAL SYMPTOMS. REVISION SURGERY WAS PERFORMED TO EXPLANT AND REPLACE THE SCREWS. THE LEVELS IMPLANTED WERE LEFT OF L2/3/4 AND A TOTAL OF THREE SCREWS WERE DEVIATED. 6.5×35 WAS RE-USED AND RE-INSERTED DURING THE REOPERATION AND REST OF THE TWO WERE DISCARDED. IT WAS CONFIRMED BY POSTOPERATIVE CT IMAGING REGARDING DEVIATION. IT IS UNKNOWN WHETHER THE CAUSE WAS A SCREW DEVIATION, BUT NEUROLOGICAL SYMPTOMS HAVE MANIFESTED. THE PROCEDURE OR TECHNIQUE PERFORMED DURING INITIAL SURGERY WAS SCOLIOSIS CORRECTION AND FIXATION AND LEVELS IMPLANTED WERE T4-L5. THE NUMBER OF DAYS HOSPITALIZED WAS EXTENDED BECAUSE OF THE REPEAT SURGERY. THE STATUS OF PATIENT WAS MENTIONED AS RECOVERING, THE REPORTED PRODUCT WAS EXPLANTED. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2564382 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC 55711015540 CA20G055

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female Hospitalization| R