BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 6586835 · Received May 24, 2017

    Report

    Report Number
    1723170-2017-02150
    Event Type
    Injury
    Date Received
    May 24, 2017
    Date of Event
    February 10, 2017
    Report Date
    May 23, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994450968
    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

    THERE WERE 13 FEMALES AND 2 MALES. IN THE MISS GROUP, WITH A MEAN AGE OF 16.5 ± 1.6 YEARS (RANGE 14¿18 YEARS). NO SPECIFIC PATIENT IDS WERE PROVIDED. ZHU, ET AL, MINIMALLY INVASIVE SCOLIOSIS SURGERY ASSISTED BY O-ARM NAVIGATION FOR LENKE TYPE 5 C ADOLESCENT IDIOPATHIC SCOLIOSIS: A COMPARISON WITH STANDARD OPEN APPROACH SPINAL INSTRUMENTATION. JNS PEDIATRICS, 19:472-478, 2017. ARTICLE CONCLUDES ON PAGE 476 THAT "HIGH ACCURACY IN PEDICLE SCREW PLACEMENT IN THE MISS GROUP WAS ACHIEVED THROUGH THE NAVIGATION OF THE O-ARM." DUE TO THE NATURE OF THIS PROCEDURE AND THE COMPLEXITY OF THE DEFORMITY, SOME SLIGHTLY INACCURATE SCREW PLACEMENTS ARE KNOWN INHERENT RISKS TO THE PROCEDURE. NO ALLEGATIONS OF MALFUNCTION. NO REQUEST FROM SITE/SURGEON FOR SYSTEM SERVICE. DEVICE NOT RETURNED OR REPAIRED.

    Description of Event or Problem · 1

    JOURNAL ARTICLE REPORTS 9 PEDICLE PERFORATIONS OCCURRED IN THE MISS (MINIMALLY INVASIVE SPINAL SURGERY) NAVIGATION GROUP. ALSO, THERE WAS ONE GRADE 3 SCREW, EIGHT GRADE 2 SCREWS,, ELEVEN GRADE 1 SCREWS, AND 125 GRADE ZERO SCREWS. PERFORATION WAS GRADED ACCORDING TO THE GERTZBEIN CLASSIFICATION. THE IMAGES WERE OBTAINED USING A BRILLIANCE CT 64-CHANNEL SCANNER (PHILIPS MEDICAL SYSTEMS) WITH THE FOLLOWING SPECIFICATIONS: 320 MAS, 120 KVP, AND 5-MM THICKNESS, WITH A 5-MM GAP BETWEEN SLICES. ADDITIONALLY, GRADE 0 AND 1 PENETRATIONS WERE CONSIDERED SATISFACTORY, WHEREAS GRADE 2 AND 3 WERE REGARDED AS PERFORATIONS. FURTHER DETAIL IN TABLE 4. POSTOPERATIVE CT SHOWED HIGH ACCURACY IN PEDICLE SCREW PLACEMENT. NO DEEP WOUND INFECTION, PSEUDARTHROSIS, ADDITIONAL SURGERY, IMPLANT FAILURE, OR NEUROLOGICAL COMPLICATIONS WERE RECORDED. ZHU, ET AL, MINIMALLY INVASIVE SCOLIOSIS SURGERY ASSISTED BY O-ARM NAVIGATION FOR LENKE TYPE 5 C ADOLESCENT IDIOPATHIC SCOLIOSIS: A COMPARISON WITH STANDARD OPEN APPROACH SPINAL INSTRUMENTATION. JNS PEDIATRICS, 19:472-478, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369768 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00613994450968

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other