BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS PORTAL

    MDR report key: 1282693 · Received November 26, 2008

    Report

    Report Number
    2135156-2008-00004
    Event Type
    Malfunction
    Date Received
    November 26, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 27, 2008
    Manufacturer
    SPINEOLOGY, INC.
    Product Code
    GEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION OF ANALYSIS: NOT CONSIDERED A NON-CONFORMING PRODUCT DUE TO SIGNIFICANT DAMAGE CAUSED BY BACK-SHAPING AND IMPACTION INTO A COMPRESSED SPACE, DEMANDS OUTSIDE OF THE DESIGN INTENT. PARTS OF THIS LOT ARE CURRENTLY BEING ROTATED OUT OF USE AND REPLACED BY NEWER DESIGN.

    Description of Event or Problem · 1

    SURGICAL CANNULA FLARED AND FRACTURED WHILE BEING DRIVEN WITH A MALLET INTO A NARROW INTERVERTEBRAL DISC SPACE. A SMALL PIECE FROM THE TIP OF THE CANNULA WAS DRIVEN INTO THE VERTEBRAL ENDPLATE AND BECAME EMBEDDED IN BONE. THE SURGEON DID NOT ATTEMPT TO RETRIEVE IT. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS PORTAL SURGICAL CANNULA GEA GEA SPINEOLOGY, INC. NA UM06002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other