BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMESH

    MDR report key: 1569125 · Received January 4, 2010

    Report

    Report Number
    2135156-2010-00001
    Event Type
    Injury
    Date Received
    January 4, 2010
    Date of Event
    June 29, 2009
    Report Date
    January 4, 2010
    Manufacturer
    SPINEOLOGY, INC.
    Product Code
    EZX
    PMA / PMN Number
    K014200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION BEING CONTAINED IN THIS REPORT IS BEING PROVIDED TO FDA TO COMPLY WITH MEDICAL DEVICE REPORTING REGULATIONS AND IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR THAT A DEVICE IS RELATED TO AN INJURY. THE DEVICE WAS DESTROYED ON REMOVAL

    Description of Event or Problem · 1

    PATIENT HAD A DEVICE IMPLANTED IN THE T12 VERTEBRAL BODY FOR A COMPRESSION FRACTURE. THE PATIENT DEVELOPED NEW SYMPTOMS POST-OPERATIVELY. A CT SCAN SHOWED THAT SOME OF THE ALLOGRAFT BONE WAS IN THE CENTRAL SPINAL CANAL. PATIENT UNDERWENT A HEMICORPECTOMY AT T12 AND THE SYMPTOMS RESOLVED POST-OPERATIVELY. THE SURGEON PRESENTED THE CASE TO SPINEOLOGY AND IT WAS REVEALED THAT THERE WERE SEVERAL ERRORS MADE UPON IMPLANTATION. THESE ERRORS INCLUDED IMPROPER PREPARATION OF THE FRACTURED VERTEBRAL BODY AND IMPROPER PLACEMENT OF THE DEVICE (PARTIALLY IN THE VERTEBRAL BODY AND PARTIALLY IN THE CENTRAL SPINAL CANAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMESH SURGICAL MESH EZX SPINEOLOGY, INC. 1500E UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention