BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE STEP OSTEO INTRODUCERSYSTEM

    MDR report key: 3042911 · Received April 9, 2013

    Report

    Report Number
    1030489-2013-00958
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 28, 2013
    Report Date
    May 3, 2013
    Manufacturer
    KYPHON NEUCHATEL
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE SHOWS THERE WAS NO MORE LIQUID IN THE BOTTLE. VISUAL ANALYSIS CONFIRMED THAT THE BOTTLE HAD BEEN BROKEN IN SOME MANNER. BASED ON THE INFORMATION PROVIDED AND VISUAL ANALYSIS, THE MOST PROBABLE ROOT CAUSE CANNOT BE CLEARLY DEFINED. IT COULD BE THAT THE BOTTLE HAD A WEAKNESS OR THE MANIPULATION DONE TO THE BOTTLE CAUSED IT TO BREAK.

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT FUNCTIONAL ANALYSIS WAS NOT POSSIBLE BECAUSE NO LIQUID WAS IN THE BOTTLE. VISUAL ANALYSIS CONFIRMED THAT THE BOTTLE HAS BROKEN IN A WRONG MANNER. BASED ON THE INFORMATION PROVIDE AND VISUAL ANALYSIS, THE MOST PROBABLE ROOT CAUSE CANNOT BE CLEARLY DEFINED. IT CAN BE DUE TO THE BOTTLE THAT HAS A WEAKNESS OR TO THE MANIPULATION DONE TO BREAK THE BOTTLE FOR ITS USE. PRESENCE OF BLOOD WAS DETECTED ON THE OSTEOINTRODUCER. DURING VISUAL ANALYSIS NO HOLE HAS BEEN DETECTED ON THE DEVICE. BASED ON THE INFORMATION PROVIDED AND VISUAL ANALYSIS, NO ROOT CAUSE COULD BE ATTRIBUTED TO THIS HOLE VISIBLE ONLY WITH X-RAY. AS THIS TOOLS HAS BEEN USED DURING THE COMPLETE SURGERY WITHOUT ISSUE THIS COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN KYPHOPLASTY AND VERTEBROPLASTY PROCEDURE, DURING THE PROCEDURE, IT WAS REPORTED THAT A HOLE WAS DISCOVERED IN THE OSTEOINTRODUCER THAT WAS VISIBLE ON X-RAY. THE PROCEDURE WAS ABLE TO BE COMPLETED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144724 ONE STEP OSTEO INTRODUCERSYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH KYPHON NEUCHATEL T15J WI12M006

    Patients

    Seq Age Sex Outcome Treatment
    1