BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2883212 · Received December 21, 2012

    Report

    Report Number
    1030489-2012-02920
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 28, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS NOT RETURNED FOR EVALUATION HOWEVER FILMS WERE SUPPLIED FOR REVIEW WHICH FOUND: AP, LATERAL AND OBLIQUE LUMBAR FILMS SHOW COMPLEX INSTRUMENTATION AT L2, L3, L4 AND L5 WITH INTERBODY CAGES AT L3/4 AND L4/5. THERE APPEARS TO BE POSTEROLATERAL GRAFT AND GOOD POSITION OF RODS AND SCREWS. NO REVISION OR CHANGES OR LOOSENING ARE DEPICTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LUMBAR SPINAL SURGERY AT L2-5. ONE MONTH POST-OP THE PATIENT UNDERWENT A REVISION SURGERY DUE TO NUMBNESS. POST-REVISION SURGERY AT UNKNOWN TIME, INFECTION OR ALLERGIC REACTION WAS CONFIRMED. AS A RESULT, AT AN UNKNOWN TIME, THE PATIENT UNDERWENT THE SECOND REVISION SURGERY TO REMOVE ALL DEVICES, AND THE AUTOBONE GRAFT WAS PERFORMED. NO ADDITIONAL INFO WAS 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

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR