BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 5882978 · Received August 17, 2016

    Report

    Report Number
    1723170-2016-03005
    Event Type
    Injury
    Date Received
    August 17, 2016
    Date of Event
    March 8, 2016
    Report Date
    October 10, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TABLE 2 STATES PATIENT DEMOGRAPHIC INFORMATION FOR THE NAVIGATED GROUP WAS 10 FEMALES/19 MALES; AVERAGE AGE 67 PLUS OR MINUS 14 YEARS; BMI 21.8 PLUS OR MINUS 6.7. NO PATIENT IDS WERE PROVIDED. OHBA, TETSURO, SHIGETO EBATA, KOJI FUJITA, HIRONAO SATO, AND HIROTAKA HARO. "PERCUTANEOUS PEDICLE SCREW PLACEMENTS: ACCURACY AND RATES OF CRANIAL FACET JOINT VIOLATION USING CONVENTIONAL FLUOROSCOPY COMPARED WITH INTRAOPERATIVE THREE-DIMENSIONAL COMPUTED TOMOGRAPHY COMPUTER NAVIGATION." EUROPEAN SPINE JOURNAL EUR SPINE J 25.6 (2016): 1775-780. DOI 10.1007/S00586-016-4489-1. 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 AND O-ARM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO MALFUNCTION ALLEGED. PEDICLE PERFORATIONS AND FACET VIOLATIONS ARE KNOWN INHERENT RISKS OF THIS PROCEDURE. USE OF THE NAVIGATION AND O-ARM SYSTEMS SIGNIFICANTLY REDUCED THE RISK OF THESE ISSUES. NO PARTS WERE REPLACED OR RETURNED.

    Additional Manufacturer Narrative · 1

    PER FURTHER REVIEW OF THE JOURNAL ARTICLE, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM PAGE 1777: NO PATIENTS NEEDED REVISION DUE TO A SCREW MISPLACEMENT IN EITHER GROUP. TABLE 3 SUMMARY OF RADIOGRAPHIC OUTCOMES BY GRADING CRITERIA GRADE ACCURACY OF PPS TECHNIQUE (NEO ET AL. GRADING) [11] CFT CT-IGN 0 57 (79.2) 114 (93.4). 1 7 (9.72) 4 (3.28), 2 6 (8.33) 2 (1.64), 3 2 (2.78) 2 (1.64). TYPE ACCURACY OF PPS TECHNIQUE (UPENDRA ET AL. GRADING) [20]. CFT CT-IGN 1 62 (86.1) 114 (93.4), 2 10 (13.8) 8 (6.56), 30 0. GRADE FACET JOINT VIOLATION (BABU ET AL. GRADING) [1]. CFT CT-IGN 0 23 (63.9) 78 (94.9), 1 7 (19.4) 2 (2.53), 2 1 (2.78) 0, 3 5 (13.9) 2 (2.53). VALUES ARE THE NUMBER OF SCREWS (%). PPS PERCUTANEOUS PEDICLE SCREW.

    Description of Event or Problem · 1

    PER THE ATTACHED ARTICLE, PERCUTANEOUS PEDICLE SCREW PLACEMENTS: ACCURACY AND RATES OF CRANIAL FACET JOINT VIOLATION USING CONVENTIONAL FLUOROSCOPY COMPARED WITH INTRAOPERATIVE THREE-DIMENSIONAL COMPUTED TOMOGRAPHY COMPUTER NAVIGATION, THE AUTHORS REVIEWED 194 PEDICLE SCREWS OF 28 CONSECUTIVE PATIENTS WHO UNDERWENT MINIMALLY INVASIVE LUMBAR OR THORACIC SPINAL STABILIZATION. THE ACCURACY OF SCREW PLACEMENT WAS EVALUATED ACCORDING TO TWO CRITERIA PUBLISHED BY NEO ET AL. AND UPENDRA ET AL. FACET JOINT VIOLATION WAS EVALUATED ACCORDING TO THE CLASSIFICATION DESCRIBED BY BABU ET AL. RESULTS UPON NEO GRADING, CFT (CONVENTIONAL FLUOROSCOPY, NO NAVIGATION SYSTEM USE) GROUP HAD 19.4 % (14/ 72) PEDICLE BREACH RATE AND CT-IGN (STEALTHSTATION NAVIGATION SYSTEM AND O-ARM IMAGING USED) GROUP HAD A 5.7 % (7/ 122) PEDICLE BREACH RATE (P\0.005). THE SAME SETS OF SCREWS WERE ALSO ASSESSED USING THE OUTCOME-BASED CLASSIFICATION ESTABLISHED BY UPENDRA. THERE WERE NO SCREW CAUSED NEUROVASCULAR INJURIES (TYPE 3 = 0) IN BOTH GROUPS. THE RESULTS SHOWED THAT 87.5 % (63/72) SCREWS HAD ACCEPTABLE PLACEMENTS (TYPE I) AND 12.5 % (9/72) HAD UNACCEPTABLE PLACEMENTS (TYPE II) IN CFT GROUP. IN CONTRAST, 94.3 % (115/122) SCREWS HAD ACCEPTABLE PLACEMENTS (TYPE I) AND ONLY 5.7 % (7/122) HAD UNACCEPTABLE PLACEMENTS (TYPE II) IN CT-IGN GROUP. ADDITIONALLY, CFT GROUP HAD A SIGNIFICANTLY HIGHER FACET JOINT VIOLATION RATE OF 30.5 % (11/36) THAN CT-IGN GROUP THAT HAD A 3.8 % (3/79) VIOLATION RATE (P\0.005). CONCLUSION: THIS STUDY INDICATED THE USE OF INTRAOPERATIVE CT IMAGING (O-ARM) NAVIGATION IN PPS (PERCUTANEOUS PEDICLE SCREW) PLACEMENT HAVE VERY BENEFICIAL IMPLICATIONS FOR MIS (MINIMALLY INVASIVE SURGERY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536328 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other