BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7

    MDR report key: 11893410 · Received May 27, 2021

    Report

    Report Number
    1723170-2021-01417
    Event Type
    Malfunction
    Date Received
    May 27, 2021
    Date of Event
    December 1, 2020
    Report Date
    May 27, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. EVENT DATE IS THE MONTH AND YEAR OF THE PUBLICATION. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: UNK_OARM_SYS, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: GIANCULA SCALIA, GIUSEPPE EMMANUELE UMANA, SANTINO OTTAVIO TOMASI, MASSIMO FURNARI, MASSIMILIANO GIUFFRIDA, GIANCARLO PONZO, GIOVANNI FEDERICO NICOLETTI. LETTER: IMAGE GUIDED NAVIGATION AND ROBOTICS IN SPINE SURGERY. NEUROSURGERY ONLINE. 2020, 87. 10.1093/NEUROS/NYAA404 LETTER: TO THE EDITOR: WE REALLY APPRECIATED THE MANUSCRIPT BY KOCHANSKI ET AL ENTITLED ¿IMAGE-GUIDED NAVIGATION AND ROBOTICS IN SPINE SURGERY¿ PUBLISHED IN JANUARY 2019 IN NEUROSURGERY. THE AUTHORS REPORTED THEIR EXPERIENCE WITH THE APPLICATION OF INNOVATIVE TECHNOLOGIES IN SPINE SURGERY SUCH IMAGE GUIDANCE (IG) AND ROBOTICS SYSTEMS. THERE IS A GROWING OF DATA SHOWING THAT IG AND ROBOTIC SYSTEMS DECREASE THE INCIDENCE OF MISPOSITIONED SCREWS. THE COMBINATION OF ROBOTIC TECHNOLOGY AND IG CAN BE VERY USEFUL IN CASES WITH ALTERED OR COMPLEX ANATOMY. THERE IS ALSO A GROWING EXTENSION OF THE INDICATIONS FOR THE USE OF THESE SYSTEMS REPORTED IN THE LITERATURE, NOT ONLY IN GUIDING THE CORRECT POSITIONING OF THE PEDICLE SCREWS, BUT ALSO IN THE CERVICAL SPINE INSTRUMENTED CASES AND IN THE SPINAL ONCOLOGICAL SURGERY. BOTH OF THESE TECHNIQUES OFFER THE POSSIBILITY OF REDUCING EXPOSURE TO IONIZING RADIATION FOR THE PATIENT AND THE TECHNICALOPERATING TEAM, WHILE OFFERING REDUCED SURGICAL TIMES, LESS MUSCLE DISSECTION, IN COMPLIANCE WITH MINIMALLY INVASIVE SPINE SURGERY. IT IS OUR PLEASURE TO SHARE WITH THE INTERNATIONAL COMMUNITY OUR EXPERIENCE WITH THE USE OF A NEW TOOL DESIGNED TO IMPROVE ACCURACY IN SPINAL NAVIGATION. AT OUR INSTITUTION, A NEW DEVICE HAS BEEN DESIGNED AND PATENTED. IN OUR DAILY PRACTICE AFTER THE CLASSIC REFERENCE FRAME PLACEMENT, A NEW ¿SCREW-LIKE¿ TOOL IS SCREWED INTO THE SAME OR ADJACENT SPINOUS PROCESS OF THE REFERENCE FRAME. THE TOOL IS COMPOSED BY A LOWER PORTION WITH A THREADED NEEDLE CONNECTED TO A RECTANGULAR-SHAPED SKIN CONTACT PLATE AND AN UPPER PORTION WITH A HEXAGONAL NUT AND A 2 MM CENTRAL PIN. A FIRST 3-DIMENSIONAL (3D) SCAN IS ACQUIRED WITH O-ARM (MEDTRONIC NAVIGATION, MEDTRONIC INC, DUBLIN, IRELAND) AND USED BY THE STEALTHSTATION S7 SURGICAL NAVIGATION SYSTEM (MEDTRONIC NAVIGATION, MEDTRONIC INC) TO CREATE AN AUTOMATIC RECONSTRUCTION OF THE SPINE. NAVIGATION ACCURACY IS INTRAOPERATIVE CHECKED TOUCHING WITH THE TIP OF THE PROBE THE PIN SURFACE OF THE SCREW-LIKE TOOL. THE PRECISE CORRESPONDENCE OF THESE LAST 2 IS CONSIDERED AS EVIDENCE OF THE ABSENCE OF MICROMOVEMENTS OF THE REFERENCE FRAME, CONVERSELY A MISMATCH SUGGESTED A LOSS OF SYSTEM CALIBRATION, SO THE EXECUTION OF A NEW 3D ACQUISITION AND CALIBRATION IS REQUIRED. WE EVALUATE PEDICLE SCREWS¿ PLACEMENT ACCURACY USING THE NEW TOOL IN ADJUNCT TO THE CLASSIC REFERENCE FRAME, FOLLOWING THE GERTZBEIN AND ROBBINS CLASSIFICATION, AND THE 98.9% ARE COMPLETELY INSIDE CORTICAL BONE (GRADE A) AND ONLY THE 1.1% WITH A BREACH OF LESS THAN 2 MM (GRADE B). OUR EXPERIENCE DEMONSTRATES THAT THE NEW ¿SCREW-LIKE¿ TOOL COUPLED TO THE CLASSIC REFERENCE FRAME DEVICE COULD IMPROVE ACCURACY DURING NAVIGATED SPINE SURGERY AND POTENTIALLY REDUCING TO ZERO THE RISKS FOR SCREW MISPOSITIONING. IN LITERATURE THERE ARE OTHER. SCREW-LIKE TOOL PROJECT TEMPLATE AND COMPLETE EQUIPMENT WITH SCREWS OF DIFFERENT SIZES AND T-SHAPED SCREWING SYSTEM. REPORTS NAVIGATION NUANCES WITH THE AIM TO IMPROVE PEDICLE SCREW ACCURACY.3,4 WE AGREE WITH KOCHANSKI ET AL1 AS THEY SUGGESTED THAT FURTHER RESEARCH IS NECESSARY TO BETTER ELUCIDATE SITUATIONS WHERE THESE REPORTED EVENT: 1.1% OF SCREWS PLACED WERE FOUND TO HAVE BREACHED BY LESS THAN TWO MILLIMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794816 STEALTHSTATION S7 NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733858

    Patients

    Seq Age Sex Outcome Treatment
    1