BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 11061797 · Received December 23, 2020

    Report

    Report Number
    1030489-2020-01840
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    December 8, 2020
    Report Date
    December 23, 2020
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. PRODUCT WAS NOT 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

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING SCREWS USED IN POSTERIOR FUSION. LEVELS IMPLANTED: T1-11. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE AIS TYPE2. IT WAS REPORTED THAT NAVIGATION WAS USED FROM CAUDAL SIDE, THE SCREW WAS INSERTED, SCREWS WERE INSERTED FROM THE CAUDAL SIDE ALTERNATELY LEFT AND RIGHT. IT WAS FELT TO BE DEVIATED A LITTLE, SO IT WAS CHECKED WITH CT WHEN COMING TO TH7. IT WAS NOTED THAT THE SCREWS OF THE 7TH, 8TH, AND 9TH THORACIC VERTEBRAE ON THE LEFT SIDE HAD DEVIATED. THE SCREW WAS INSERTED WITH NAVI, BUT IT DID NOT PASS THROUGH THE PEDICLE AND WAS STUCK IN THE SPINAL CANAL. AFTER THAT, THE SCREW WAS INSERTED WITHOUT USING NAVI WITH NO PROBLEM. HOWEVER, THE NUMBER OF NERVE MONITORING DROPPED SIGNIFICANTLY. AFTER THE OPERATION LEG MOVED, BUT IT IS UNKNOWN AT THIS TIME WHETHER THERE WERE SEQUELAE. THE SCREWS WERE INSERTED AGAIN, AND THE OPERATION WAS PROCEEDED AND COMPLETED. IMPLANT PRODUCTS ARE BEING IMPLANTED. THERE WAS NO PATIENT HEALTH DAMAGE PROBLEM. THERE WAS A DELAY OF LESS THAN 60 MIN IN OVERALL PROCEDURE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527065 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK USA, INC 55711015540 CA17G084

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR