BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 1905124 · Received November 22, 2010

    Report

    Report Number
    1030489-2010-01488
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    MAX
    PMA / PMN Number
    K073291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL REVIEW CONFIRMS THE INFERIOR TANG IS BROKEN OFF ON THE INSTRUMENT, AND THE SUPERIOR TANG IS CRACKED, CONSISTENT WITH BEND STRESS OVERLOAD. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACES REVEALS A FAIRLY TORTUOUS FRACTURE, WITH NO INDICATION OF FATIGUE. THE NATURE AND LOCATION OF THE FRACTURE SURFACE IS CONSISTENT WITH EXCESSIVE BENDING FORCE. A REVIEW OF DEVICE HISTORY RECORDS IS NOT POSSIBLE AT THIS TIME WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT METAL TIP OF THE INSERTER BROKE OFF DURING INSERTION. THE BROKEN PIECE WAS REMOVED AND THE IMPLANT WAS NOT DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK USA, INC NA MA05C009

    Patients

    Seq Age Sex Outcome Treatment
    1