BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 11397300 · Received March 2, 2021

    Report

    Report Number
    1030489-2021-00274
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Report Date
    March 2, 2021
    Manufacturer
    WARSAW ORTHOPEDICS
    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

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT MARKETED IN US. PMA 510K NO. IS K121680 FOR SIMILAR DEVICE MARKETED IN US WITH PRODUCT ID AS 1475006500. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED IN A WHO HAD AN OPERATION ON (B)(6)2014. IT WAS REPORTED THAT BOTH SIDES OF THE RODS WERE BROKEN AND FRAGMENT IS REMAINING IN THE PATIENT. RE-OPERATION WAS PERFORMED ON (B)(6) 2021, USING EIGHT MRC AND RE-FIXING WITH DUAL ROD. THERE WERE NO MALFUNCTIONS OR ADVERSE EVENTS DURING THE OPERATION, AND THERE WERE NO REPORTS OF MALFUNCTIONS AFTER THE OPERATION. THE PRODUCTS WILL NOT BE RETURNED FROM THE HOSPITAL. PRODUCT WILL NOT BE RETURNED SINCE IT REMAINS IN PATIENT. PATIENT HEALTH HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296898 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS 1476106210 0263618W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention