BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 4097196 · Received September 17, 2014

    Report

    Report Number
    1723170-2014-00989
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 15, 2012
    Report Date
    August 19, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, GENDER AND WEIGHT WERE NOT MADE AVAILABLE. EVENT DATE: (B)(6) 2013 IS AN ESTIMATED DATE TAKEN FROM THE JOURNAL ARTICLE: CLINICAL AND RADIOGRAPHIC OUTCOMES OF MINIMALLY INVASIVE PERCUTANEOUS PEDICLE SCREW PLACEMENT WITH INTRAOPERATIVE CT (O-ARM) IMAGE GUIDANCE NAVIGATION. (1 OF 3). CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED BY THE SITE. SYSTEM HAS BEEN USED SUCCESSFULLY MULTIPLE TIMES SINCE THE REPORTED ISSUE. NO PARTS HAVE BEEN REPLACED OR RETURNED TO MANUFACTURER FOR ANALYSIS. (B)(4) 2014 A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. JOURNAL ON-LINE: HTTP://THEJNS.ORG/DOI/ABS/10.3171/2014.1.FOCUS13531. 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.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE, REGISTERED NURSE (RN), REPORTED AN EVENT THAT WAS IDENTIFIED IN A JOURNAL ARTICLE: CLINICAL AND RADIOGRAPHIC OUTCOMES OF MINIMALLY INVASIVE PERCUTANEOUS PEDICLE SCREW PLACEMENT WITH INTRAOPERATIVE CT (O-ARM) IMAGE GUIDANCE NAVIGATION. (1 OF 3). AUTHORS: TERRENCE T. KIM, M.D., DONIEL DRAZIN, M.D., FARIS SHWEIKEH, B.S., ROBERT PASHMAN, M.D., AND J. PATRICK JOHNSON, M.D. THE ATTACHED ARTICLE STATES THAT 5 LATERAL PEDICLE BREACHES OCCURRED IN FIVE PATIENTS UNDERGOING MINIMALLY INVASIVE SPINE SURGERY BETWEEN JULY 2010 AND AUGUST 2013. ONE OF THE BREACHES WAS GRADE 3 (GREATER THAN 4MM), ALL OTHERS WERE GRADE 1 OR 2. NO VASCULAR OR NEUROLOGICAL COMPLICATIONS WERE OBSERVED INTRAOPERATIVELY, AND NO SIGNIFICANT POSTOPERATIVE COMPLICATIONS WERE NOTED. THE MEAN CLINICAL FOLLOW-UP PERIOD WAS 18 MONTHS (RANGE 3-39 MONTHS). THE OVERALL CLINICAL OUTCOMES, MEASURED USING THE VISUAL ANALOG SCALE (BACK PAIN SCORES), WERE IMPROVED SIGNIFICANTLY POSTOPERATIVELY AT 3 MONTHS COMPARED WITH PREOPERATIVELY (VISUAL ANALOG SCORE 6.35 VS 3.57; P < 0.0001). NO REVISION SURGERY WAS PERFORMED FOR SCREW MISPLACEMENT OR NEUROLOGICAL DETERIORATION. IN ADDITION, 5 OTHER BREACHES OCCURRED IN 2 PATIENTS WHICH ARE SPECIFICALLY CALLED OUT IN THE ATTACHED LITERATURE. PLEASE SEE AN ADDITIONAL 2 SEPARATE MDRS 1723170-2014-00990 AND 1723170-2014-00991 WHICH WILL BE SUBMITTED FOR EACH OF THE PATIENTS WHOSE SURGICAL CIRCUMSTANCES ARE SPECIFICALLY CALLED OUT IN THE LITERATURE. CONCLUSIONS. NEW CT-IGN WITH THE MOBILE O-ARM SCANNER HAS INCREASED THE ACCURACY OF PEDICLE SCREW/INSTRUMENTATION PLACEMENT USING MIS TECHNIQUES. THE AUTHORS' HIGH (96.6%) ACCURACY RATE IN MIS COMPARES FAVORABLY WITH HISTORICAL PUBLISHED ACCURACY RATES FOR FLUOROSCOPY-BASED TECHNIQUES. ADDITIONAL ADVANTAGES OF CT-IGN OVER FLUOROSCOPIC IMAGING METHODS ARE LOWER OCCUPATIONAL RADIATION EXPOSURE FOR THE SURGICAL TEAM, REDUCED NEED FOR POSTOPERATIVE IMAGING, AND DECREASED RATES OF REVISION SURGERY. FOR NOW, THE AUTHORS SIMPLY CONCLUDE THAT USE OF INTRAOPERATIVE CT-IGN IS SAFE AND ACCURATE. (HTTP://THEJNS.ORG/DOI/ABS/10.3171/2014.1.FOCUS13531). 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
    576438 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention