BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2313508 · Received October 28, 2011

    Report

    Report Number
    1030489-2011-01400
    Event Type
    Malfunction
    Date Received
    October 28, 2011
    Report Date
    September 28, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE OR APPLICABLE IMAGING STUDIES HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT APPROVED FOR SALE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE, PART NUMBER 76446540, 510K NUMBER K042025, IS APPROVED FOR SALE IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION SURGERY TO REMOVE AND REPLACE AN INTERBODY DEVICE, IT WAS NOTICED THAT THE PEDICLE SCREWS AT S1 WERE LOOSE IN THE BONE IN THE L5-S1 POSTERIOR CONSTRUCT. THE LOOSENED SCREWS WERE REPLACED AND FIXATION WAS EXTENDED TO THE ILIAC. THE SURGEON NOTED THAT THE PATIENT HAD POOR BONE SUBSTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR PEEK INTERBODY DEVICE