BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3213387 · Received July 9, 2013

    Report

    Report Number
    1723170-2013-00502
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 7, 2013
    Report Date
    June 11, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ALLEGATIONS WERE MADE OF MEDTRONIC NAVIGATION'S DEVICE CAUSING OR CONTRIBUTING TO THE PATIENT EVENT. A MEDTRONIC REPRESENTATIVE FOLLOWING-UP AT THE SITE GATHERED MORE DETAILS: THE SURGEON PERFORMED THE SCOLI SPINE FUSION USING A STEALTHSTATION S7 SYSTEM AND AN O-ARM SYSTEM WITH DEMO NAVLOCK/SOLERA PROBE AND TAPS FOR THE SCREW HOLE, THE SCREWS WERE PLACED WITHOUT NAVIGATION. THE CSF LEAK WAS ON ONE OF THE SCOLI VERTEBRA, THERE WAS ABSOLUTELY NO ALLEGATION OF DEFICIENCY WITH NAVIGATION OR WITH ANY MEDTRONIC NAVIGATION, INC. INSTRUMENTATION. THE CSF LEAK WAS STOPPED, MATERIAL USED WAS UNKNOWN. SURGERY WAS COMPLETED SUCCESSFULY WITH NAVIGATION. PER SITE ORTHO COORDINATOR, PATIENT DID NOT REQUIRE ANY FOLLOW-UP/ADDITIONAL SURGERY. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE PRESENT AT THE SITE, REPORTED THAT WHILE IN A PEDIATRIC SCOLI SPINE PROCEDURE, A CEREBROSPINAL FLUID LEAK (CSF} OCCURED. THE SURGEON MADE NO ALLEGATION OF A MALFUNCTION OF ANY MEDTRONIC NAVIGATION DEVICE IN RELATION TO THIS EVENT. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION S7 SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312799 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR