BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 2862595 · Received December 10, 2012

    Report

    Report Number
    1030489-2012-02713
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 9, 2012
    Report Date
    February 7, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT# OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT # H11E1803 AND # H11E1814 (MANUFACTURED DATE FOR LOT#S IS 2011-05-27).

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A PATIENT WITH LUMBAR DEGENERATIVE SCOLIOSIS UNDERWENT A PROCEDURE USING A CAGE AND SCREWS WITH POSTERIOR FIXATION. IT WAS REPORTED THAT THE SCREW HAS LOOSENED AND THE CAGE BACKED OUT TOWARD SPINAL CANAL AT UNKNOWN TIME POST-OP. BONE UNION HAS NOT OCCURRED, AND THE PATIENT DEVELOPED PSEUDARTHROSIS. REOPERATION IS PLANNED FOR REMOVAL OF THE CAGE AND REPLACING SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON® SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H11E1798

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention