BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 646834 · Received November 11, 2005

    Report

    Report Number
    1030489-2005-00347
    Event Type
    Injury
    Date Received
    November 11, 2005
    Date of Event
    October 12, 2005
    Report Date
    October 13, 2005
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE: 10/06/2005. IT WAS REPORTED THAT "WHEN THE PT STOOD UP" SIX DAYS AFTER SURGERY (2005), "PARALYSIS APPEARED." A REVISION SURGERY WAS PERFORMED THE NEXT DAY TO REMOVE THE IMPLANTS. "THE PT IS UNDER OBSERVATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SPINAL FIXATION SYSTEM LXH WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention