BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 5887275 · Received August 18, 2016

    Report

    Report Number
    1723170-2016-03052
    Event Type
    Injury
    Date Received
    August 18, 2016
    Date of Event
    September 21, 2015
    Report Date
    August 18, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO REQUEST FOR SERVICE HAVE BEEN RECEIVED FROM THE CUSTOMER REGARDING THESE EVENTS. NO PARTS HAVE BEEN REPLACED OR RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    PER ATTACHED JOURNAL ARTICLE, SCREW PLACEMENT ACCURACY AND OUTCOMES FOLLOWING O-ARM-NAVIGATED ATLANTOAXIAL FUSION- A FEASIBILITY STUDY, BETWEEN 2011 AND 2014, SEVEN PATIENTS UNDERWENT POSTERIOR ATLANTOAXIAL FUSION USING INTRAOPERATIVE FRAMELESS STEREOTACTIC O-ARM SURGICAL IMAGING AND STEALTH-STATION SURGICAL NAVIGATION SYSTEM (MEDTRONIC, INC., (B)(4)). OUTCOME MEASURES INCLUDED SCREW ACCURACY, NEUROLOGIC STATUS, RADIATION DOSING, AND SURGICAL COMPLICATIONS. NO COMPLICATIONS OCCURRED DURING SURGERY, SUCH AS VERTEBRAL ARTERY, NERVE ROOT, OR SPINAL CORD INJURY. THE INITIAL INTRAOPERATIVE CT WAS USED TO DETERMINE THE PROPER CERVICAL ALIGNMENT OF THE PATIENT; NO PATIENTS REQUIRED REPOSITIONING PRIOR TO THE SURGERY. THE MEAN OPERATIVE TIME WAS 188.7 MINUTES (RANGE 155 TO 213), AND THE MEAN BLOOD LOSS WAS 271.4 ML (RANGE 50 TO 900). THE PATIENTS RECEIVED ON AVERAGE 39.0 MGY OF RADIATION WITH USE OF THE O-ARM. VALUES FROM THE OPERATIVE RECORDS ARE SHOWN IN TABLE 2. A TOTAL OF 30 SCREWS WERE PLACED IN THE CERVICAL SPINE: 14 SCREWS (46.7%) IN C1, 8 SCREWS (26.7%) IN C2, AND 8 SCREWS (26.7%) IN C3. IN THREE INSTANCES, THE C2 ANATOMY WAS DETERMINED TO BE NOT CONDUCIVE TO SCREW PLACEMENT, SO C3 WAS USED AS THE SITE OF INSTRUMENTATION INSTEAD. THIS C2 ANATOMY WAS NOT EVIDENT ON THE PREOPERATIVE CT. IN ONE INSTANCE, IT WAS DEEMED NECESSARY TO PLACE THE SCREWS IN EACH OF THE FIRST THREE CERVICAL VERTEBRAE. A TOTAL OF TWO PEDICLE SCREWS (25%) WERE CLASSIFIED AS GRADE 0 (TABLE 3). TWO SCREWS (25%), 4 SCREWS (50%), AND 0 SCREWS (0%) WERE GRADED AS 1, 2, AND 3, RESPECTIVELY (TABLE 3). ALL C2 PEDICLE SCREWS DEVIATED MEDIALLY. THE AVERAGE DEVIATION FOR ALL C2 PEDICLE SCREWS WAS 1.5 MM, AND NO SCREWS HAD CORTICAL VIOLATION. THE LATERAL MASS SCREWS PLACED IN THE FIRST AND/OR THIRD CERVICAL VERTEBRA HAD AN AVERAGE DEVIATION OF 2.1 MM. ALL BUT TWO WERE CLASSIFIED AS TYPE I OR IDEAL PLACEMENT (TABLE 4). NO SCREWS REQUIRED REPOSITIONING. THE POSTOPERATIVE COURSE WAS UNEVENTFUL FOR ALL PATIENTS. THE AVERAGE LENGTH OF STAY WAS 2.7 DAYS (RANGE 1 TO 6). THE MEAN FOLLOW-UP WAS 12 MONTHS FOR PATIENTS WHO UNDERWENT ATLANTOAXIAL FUSION. AT FOLLOW-UP, ONLY ONE PATIENT SHOWED MOTION ON FLEXION¿EXTENSION FILMS, BUT SUBSEQUENT CT IMAGING DEMONSTRATED INTACT INSTRUMENTATION AND SOLID FUSION. THE PATIENTS LARGELY SAW IMPROVEMENT IN SYMPTOMS AND WERE PLEASED WITH THE SURGERY. ALL PATIENTS SHOWED SIGNS OF FUSION ON X-RAY PERFORMED AT 12 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538140 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other