BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 4394189 · Received January 7, 2015

    Report

    Report Number
    1030489-2015-00060
    Event Type
    Injury
    Date Received
    January 7, 2015
    Date of Event
    November 16, 2010
    Report Date
    December 9, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: M MACHINO; ET AL. ¿POSTERIOR/ANTERIOR COMBINED SURGERY FOR THORACOLUMBAR BURST FRACTURES-POSTERIOR INSTRUMENTATION WITH PEDICLE SCREWS AND LAMINAR HOOKS, ANTERIOR DECOMPRESSION AND STRUT GRAFTING¿. SPINAL CORD (2011) 49, 573¿579 (B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE TITLED ¿POSTERIOR/ANTERIOR COMBINED SURGERY FOR THORACOLUMBAR BURST FRACTURES-POSTERIOR INSTRUMENTATION WITH PEDICLE SCREWS AND LAMINAR HOOKS, ANTERIOR DECOMPRESSION AND STRUT GRAFTING¿ THAT 100 ((B)(6)) PATIENTS WERE SURGICALLY MANAGED WITH POSTERIOR INSTRUMENTATION, ANTERIOR DECOMPRESSION AND ANTERIOR GRAFTING. ONE PATIENT WAS REPORTED TO HAVE A NON-UNION. THE PATIENT UNDERWENT A REVISION SURGERY AND FUSED CONSEQUENTLY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13746 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention