BEUDAMED
    FDA Adverse Event Other Summary report: N

    KYPHX BONE BIOSPY DEVICE

    MDR report key: 501910 · Received December 15, 2003

    Report

    Report Number
    2953769-2003-00011
    Event Type
    Other
    Date Received
    December 15, 2003
    Date of Event
    November 12, 2003
    Report Date
    November 12, 2003
    Manufacturer
    KYPHON, INC.
    Product Code
    MJG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT BEING TREATED FOR A L1 PARTIALLY HEALED TRAUMATIC FRACTURE. THE SURGEON GAINED ACCESS TO THE VERTEBRAL BODY WITHOUT DIFFICULTY USING A TRANSPEDICULAR APPROACH. HE DECIDED TO TAKE A BONE BIOPSY DURING THE PROCEDURE. ALL THOUGH THE PRODUCT INSTRUCTION FOR USE INSTRUCTS NOT TO MALLET THE BONE BIOPSY TOOL, THE SURGEON USED A MALLET TO AID IN ITS INSERTION AS IS HIS PRACTICE WITH OTHER INSTRUMENTS. THE BIOPSY TOOL BECAME WEDGED INTO A PORTION OF THE HARD SUPERIOR ENDPLATE THAT HAD BEEN DISPLACED DOWNWARD INTO THE BODY OF THE VERTEBRA AS A RESULT OF THE ORIGINAL TRAUMA. WHILE ATTEMPTING TO REMOVE THE BIOPSY TOOL, IT BROKE AND A PIECE REMAINED IN THE PATIENT. RADIOGRAPHS CONFIRMED THAT THE FRAGMENT OF THE BONE BIOPSY DEVICE WAS COMPLETELY WITHIN THE BOUNDARIES OF THE VERTEBRAL BODY. THE PROCEDURE WAS COMPLETED WITHOUT DIFFICULTY AND THE INSTRUMENT FRAGMENT WAS ENCASED IN THE BONE CEMENT AND THERE WERE NO CLINICAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX BONE BIOSPY DEVICE BONE BIOPSY DEVICE MJG KYPHON, INC. NA 03071803

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Disability