BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIMESH

    MDR report key: 1375351 · Received February 27, 2009

    Report

    Report Number
    2135156-2009-00001
    Event Type
    Malfunction
    Date Received
    February 27, 2009
    Date of Event
    January 17, 2009
    Report Date
    January 17, 2009
    Manufacturer
    SPINEOLOGY, INC.
    Product Code
    EZX
    PMA / PMN Number
    K014200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF IMAGING SHOWS A LARGE SHARP FRAGMENT OF INFERIOR ENDPLATE PROJECTING CENTRALLY INTO THE VERTEBRA. THIS FRAGMENT MAY HAVE CAUSED DAMAGE TO THE MESH, EITHER INTRAOPERATIVELY, OR POSTOPERATIVELY.

    Description of Event or Problem · 1

    PATIENT WAS TREATED FOR A T12 BURST FRACTURE WITH COMMINUTED ENDPLATES, LATERAL AND POSTERIOR WALL FRACTURES AND A SIGNIFICANT CENTRAL CLEFT UPON EXTENSION. MESH AND BONE GRAFT WERE PLACED IN THE ANTERIOR PORTION OF THE VERTEBRA, RESULTING IN GOOD VERTEBRAL HEIGHT RESTORATION AND GOOD PAIN RELIEF. DURING THE FOLLOWING WEEK SHE DEVELOPED INCREASING BACK PAIN AND NEW HIP PAIN. A CT TAKEN 9 DAYS LATER SHOWS BONE IN THE MUSCLE AND SOFT TISSUE LATERAL TO THE VERTEBRA. SHE WAS TREATED WITH A SUPPLEMENTAL VERTEBROPLASTY (PMMA INJECTION) PLUS STEROIDS AND PAIN MEDICATION. BACK AND HIP PAIN HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMESH GRAFT CONTAINMENT DEVICE EZX SPINEOLOGY, INC. 1500E S07010

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization