BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTE-STACK SPINAL SYSTEM

    MDR report key: 1241244 · Received November 6, 2008

    Report

    Report Number
    1030489-2008-00616
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 17, 2006
    Report Date
    October 7, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    NEK
    PMA / PMN Number
    K041556
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TLIF AT L5-S1 USING INTERBODY DEVICE WITH RHBMP-2/ACS AND POSTERIOR INSTRUMENTATION. THE PATIENT WAS HOSPITALIZED FOR LOWER BACK SPASMS APPROXIMATELY 6 WEEKS POST OP. NO NEUROLOGICAL DEFICIT WAS DETECTED. X-RAY AND CT SCANS SHOWED THAT THE CAGE HAD MOVED POSTERIORLY AND APPEARED TO BE COMPRESSING THE L5 NERVE ROOT. THE PATIENT UNDERWENT A SURGICAL REVISION APPROXIMATELY 7 WEEKS POST OP TO ADJUST THE CAGE AND INSERT TWO PEDICLE SCREWS FOR STABILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTE-STACK SPINAL SYSTEM VB REPLACEMENT NEK WARSAW ORTHOPEDIC INC. NA W06F2578

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention