BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 4101098 · Received September 19, 2014

    Report

    Report Number
    1030489-2014-03717
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    PMA / PMN Number
    K050809
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE INSTRUMENT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TLIF SURGERY AT LEVELS L4/L5/S1. PATIENT EXPERIENCED REOCCURRING BACK PAIN SIX MONTHS POSTOP. THERE WAS A BROKEN SCREW AT S1 AND HARDWARE WAS LOOSE. NO FRAGMENTS OF BROKEN SCREW REMAINED IN PATIENT. THE BROKEN SCREW WAS REMOVED AND REPLACED. ALSO, NEW RODS AND SET SCREWS WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584805 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention RODS, SET SCREWS