BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2082645 · Received May 10, 2011

    Report

    Report Number
    1030489-2011-00532
    Event Type
    Injury
    Date Received
    May 10, 2011
    Report Date
    April 15, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    NQP
    PMA / PMN Number
    K060615
    Removal / Correction Number
    1030489-122107-009-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE OR APPLICABLE IMAGING STUDIES HAVE NOT BEEN PROVIDED TO MEDTRONIC FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT THE PATIENT UNDERWENT A TLIF AT L4-5, L5-S1 FOLLOWED BY DECOMPRESSION LAMINECTOMY AND POSTERIOR SPINAL FUSION WITH INSTRUMENTATION AT L3-S1. ON (B)(6) 2009 THE PATIENT UNDERWENT REMOVAL OF HARDWARE, EXPLORATION OF FUSION, AND ADDITIONAL POSTERIOR FUSION WITH INSTRUMENTATION AT L3-4.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE PATIENT'S MEDICAL RECORDS THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2006 FOR TLIF L4-5, L5-S1, DECOMPRESSION LAMINECTOMY, AND POSTERIOR SPINAL FUSION INSTRUMENTED AT L4-5-S1 AND DYNAMIC STABILIZATION AT L3-4 WITH DYNAMIC ROD. X-RAYS TAKEN (B)(6) 2008 SHOWED A RIGHT SIDED ROD CABLE FAILURE WITH ANTEROLISTHESIS AT L3-4. ON (B)(6) 2009 THE PATIENT UNDERWENT A PROCEDURE FOR HARDWARE REMOVAL AND POSTERIOR SPINAL FUSION AT L3-4. SOLID FUSION WAS NOTED AT L4-S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION NQP WARSAW ORTHOPEDIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention