BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2113642 · Received June 3, 2011

    Report

    Report Number
    1030489-2011-00675
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 9, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. A REVIEW OF DEVICE HISTORY RECORDS IS NOT POSSIBLE AT THIS TIME WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE TO EXTEND POSTERIOR FIXATION AFTER GROWING. THE PROCEDURE WAS SCHEDULED ON A REGULAR BASIS TO REPLACE THE RODS WITH LONGER ONES AS HER BONE GROWS. DURING THE EXTENSION PROCEDURE IT WAS FOUND THAT THE ROD IMPLANTED BROKE. THE BROKEN ROD WAS REPLACED TO A LONGER ROD AS PLANNED. EXTENSION OF OPERATION TIME WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1