BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2072713 · Received April 29, 2011

    Report

    Report Number
    1030489-2011-00471
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 29, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K031655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION HOWEVER FILMS WERE SUPPLIED FOR REVIEW. MEDICAL ADVISOR FOUND AP AND LATERAL X-RAYS OF L1 BURST/COMPRESSION FRACTURE TREATED WITH PEDICLE SCREWS, NON-CONTOURED RODS AND CROSSLINK AT T12-L2. LOWER SET SCREWS HAVE BACKED OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A 3 LEVEL POSTERIOR LATERAL MASS FUSION TO TREAT A BURST FRACTURE. THE PATIENT RETURNED APPROXIMATELY 6 YEARS POST-OP WITH PAIN AND A FEELING THAT THE IMPLANTS ARE MOVING WHEN THE PATIENT MOVES. X-RAYS REVEALED THAT THE SET SCREWS HAVE BACKED OUT OF THE BONE SCREW. A REVISION SURGERY HAS NOT BEEN SCHEDULED YET DUE TO COMPLICATIONS WITH THE PATIENT'S INSURANCE COMPANY. FUSION HAS OCCURRED NO ADDITIONAL PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention RODS, BONE SCREWS, BONE CHIPS