BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 5926701 · Received September 2, 2016

    Report

    Report Number
    1723170-2016-02118
    Event Type
    Injury
    Date Received
    September 2, 2016
    Date of Event
    June 14, 2016
    Report Date
    September 2, 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

    PATIENT ID AND WEIGHTS WERE NOT PROVIDED. KOMATSUBARA, T., MD, TOKIOKA,, T., MD, SUGIMOTO, Y., MD,& OZAKI, T., MD. (2016) MINIMALLY INVASIVE CERVICAL PEDICLE SCREW FIXATION BY A POSTEROLATERAL APPROACH FOR ACUTE CERVICAL INJURY. CLIN SPINE SURG. 00 (00), 1-4. THERE IS NO ALLEGATION IN THE ARTICLE THAT A MALFUNCTION OF THE NAVIGATION SYSTEM CAUSED THE SCREW MISPLACEMENTS. SCREW MISPLACEMENTS ARE A KNOWN INHERENT RISK TO THIS TYPE OF PROCEDURE DUE TO THE NATURE OF THE ANATOMY. NO PARTS WERE REPLACED OR RETURNED. SERVICE WAS NOT REQUESTED FOR THE SYSTEM IN RELATION TO THESE EVENTS.

    Description of Event or Problem · 1

    MINIMALLY INVASIVE CERVICAL PEDICLE SCREW FIXATION BY A POSTEROLATERAL APPROACH FOR ACUTE CERVICAL INJURY BY KOMATSUBARA ET AL., THE POSITIONS OF 203 SCREWS WERE ASSESSED BY COMPUTED TOMOGRAPHY (TABLE 2). CLINICALLY SIGNIFICANT SCREW DEVIATION IN THE PRESENT STUDY WAS CONSIDERED GRADE 2 OR 3, AND THE INCIDENCE WAS SIGNIFICANTLY LOWER IN THE MICEPS (MINIMALLY INVASIVE CERVICAL PEDICLE SCREW) FIXATION GROUP THAN IN THE CONVENTIONAL CERVICAL PEDICLE SCREW GROUP (P=0.0039; ODDS RATIO, 0.12; CI, 0.02¿0.6). IN THE CONVENTIONAL CERVICAL PEDICLE SCREW GROUP, 71 SCREWS (88%) WERE CLASSIFIED AS GRADE 0 OR 1, AND 10 SCREWS (12%) WERE CLASSIFIED AS GRADE 2 OR 3, OF WHICH 4 HAD A LATERAL DEVIATION AND 6 HAD A MEDIAL DEVIATION. IN THE MICEPS FIXATION GROUP, 120 SCREWS (98%) WERE CLASSIFIED AS GRADE 0 OR 1 (FIG. 2) AND 2 SCREWS (2%) WERE CLASSIFIED AS GRADE 2 OR 3 WITH A MEDIAL DEVIATION. THE MEDIAL AND LATERAL DEVIATION OF THE SCREW WAS CLASSIFIED INTO 4 GRADES: GRADE 0, NO DEVIATION; GRADE 1, DEVIATION < 2 MM; GRADE 2, DEVIATION > 2 AND< 4 MM; AND GRADE 3, DEVIATION > 4 MM. IN THE MICEPS FIXATION GROUP, WE WERE ABLE TO FOLLOW 27 OF THE 37 PATIENTS FOR 6 MONTHS. BONY UNION WAS COMPLETE IN ALL 27 PATIENTS. THERE WAS NOT ANY DEEP WOUND INFECTION IN BOTH GROUPS. ALL PEDICLE SCREWS WERE INSERTED USING SPINAL NAVIGATION SYSTEM IN THE BOTH GROUPS. 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. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575849 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other