BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3033804 · Received April 3, 2013

    Report

    Report Number
    1030489-2013-00931
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    April 9, 2009
    Report Date
    March 25, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    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
    MA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF POST-OPERATIVE X-RAYS CONFIRMS RIGHT ROD CABLE FAILURE AT THE BUMPER.

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE PATIENT'S MEDICAL RECORDS THAT THE PT. WITH L4-5 AND L5-S1 DEGENERATIVE DISC DISEASE UNDERWENT SURGERY FOR L5-S1 TLIF WITH PEEK INTERBODY CAGE, L4-S1 PEDICLE SCREW INSTRUMENTATION WITH DYNAMIC RODS, AND L5-S1 POSTEROLATERAL FUSION. APPROXIMATELY 20 MONTHS POST-OP RECORDS INDICATE A PARTIAL FAILURE OF THE ROD ON THE RIGHT, BETWEEN L4-L5. APPROXIMATELY 22 MONTHS POST-OP THE PATIENT UNDERWENT ADDITIONAL SURGERY DUE TO NONUNION AT L5-S1 AND BROKEN ROD AT L4-5. PROCEDURE WAS FOR REMOVAL OF POSTERIOR FIXATION, TLIF AT L4-5 WITH INTERBODY CAGE, REPLACEMENT OF L4-S1 POSTERIOR INSTRUMENTATION, AND POSTEROLATERAL FUSION L4-S1.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT THE PATIENT UNDERWENT SURGERY AND DURING SURGERY A DYNAMIC SPINAL ROD WAS IMPLANTED. APPROXIMATELY 22 MONTHS POST-OP, THE ROD CABLE WAS FOUND BROKEN. THE PATIENT UNDERWENT A SECOND OPERATION TO REMOVE THE DEVICE. REPORTEDLY, THE PATIENT INITIALLY DID WELL, BUT 1 YEAR LATER DEVELOPED BACK PAIN "WHICH HAS BEEN RECALCITRANT TO A VARIETY OF TREATMENTS INCLUDING SPINAL NERVE BLOCKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136720 CD HORIZON SPINAL SYSTEM POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION NQP WARSAW ORTHOPEDICS NA AT2007011032

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention