BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION TRIA NAVIGATION SYSTEM

    MDR report key: 5830398 · Received July 28, 2016

    Report

    Report Number
    1723170-2016-01293
    Event Type
    Injury
    Date Received
    July 28, 2016
    Date of Event
    May 19, 2016
    Report Date
    July 28, 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 IDS WERE NOT PROVIDED BY THE AUTHOR(S). SEX (MALE/FEMALE) 84/44. MEAN AGE AT SURGERY (YEARS) 65.5 (15¿92). PATIENT WEIGHTS WERE NOT PROVIDED BY THE AUTHOR(S). SHIMOKAWA, NOBUYUKI, AND TOSHIHIRO TAKAMI. "SURGICAL SAFETY OF CERVICAL PEDICLE SCREW PLACEMENT WITH COMPUTER NAVIGATION SYSTEM." NEUROSURGICAL REVIEW NEUROSURG REV (2016) DOI: 10.1007/S10143-016-0757-0 THE ARTICLE STATES THE FOLLOWING FACTORS WHICH CAN AFFECT PEDICLE SCREW PLACEMENT ACCURACY: INTERVERTEBRAL ANATOMICAL RELATIONSHIPS WITH THE PATIENT IN THE PRONE POSITION DURING SURGERY MIGHT NOT MATCH THE PREOPERATIVE CT DATA OBTAINED WHILE THE PATIENT WAS IN THE SUPINE POSITION. THIS DISCREPANCY HAS LED TO NAVIGATION ERRORS. INTRAOPERATIVE 3D CT-BASED NAVIGATION SYSTEM MAY BE THE SOLUTION FOR NAVIGATION ERRORS. IT CAN REDUCE THE DISCREPANCY SO THAT IT MAY PROVIDE GREATER ACCURACY AND FEASIBILITY DURING CPS PLACEMENT. CPS (CERVICAL PEDICLE SCREW) MISPLACEMENT WAS MORE RECOGNIZED IN C7 COMPARED TO THE OTHER SPINE LEVEL, AND THE MISPLACEMENT TO LATERAL DIRECTION TENDED TO OCCUR IN MIDLOWER CERVICAL SPINE. CPS AT C7 IS USUALLY APPLIED IN CASE OF POSTERIOR CERVICAL LONG FUSION, AND PLACED AT THE CAUDAL SIDE OF FUSION SEGMENT. THE PROCEDURE OF CPS PLACEMENT AT C7 LEVEL MAY BE EASILY AFFECTED BY THE INWARD PRESSURE OF WELL DEVELOPED PARAVERTEBRAL MUSCLE LAYERS. THE STRONGER THE AXIAL TRAJECTORY IS KEPT AGAINST THE MEDIAL PRESSURE FROM THE PARAVERTEBRAL MUSCLES, THE EASIER THE AXIAL ROTATION OR SAGITTAL BENDING OF THE CERVICAL SPINE MIGHT BE, SO THAT SCREWS MAY BE MISPLACED LATERALLY. THE ACCURACY OF CPS PLACEMENT MAY BE ALSO AFFECTED BY ANATOMICAL COMPLEXITY OF CERVICAL PEDICLE OR NAVIGATION ERROR.

    Description of Event or Problem · 1

    PER ATTACHED ARTICLE: CERVICAL PEDICLE SCREW (CPS) MAY BE THE BIOMECHANICALLY BEST SYSTEM FOR POSTERIOR CERVICAL SEGMENTAL FIXATION, BUT MAY CARRY A SURGERY-RELATED RISK. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE SAFETY OF CPS PLACEMENT USING COMPUTER NAVIGATION SYSTEM FOR POSTERIOR CERVICAL INSTRUMENTED FIXATION AND DISCUSS ITS COMPLICATION AVOIDANCE AND MANAGEMENT. POSTERIOR CERVICAL INSTRUMENTED FIXATION USING CPS WAS PERFORMED IN A TOTAL OF 128 PATIENTS DURING THE PERIOD BETWEEN 2007 AND 2015. INTRAOPERATIVE IMAGE GUIDANCE WAS ACHIEVED USING A PREOPERATIVE 3D CT-BASED OR AN INTRAOPERATIVE 3D CTBASED NAVIGATION SYSTEM. A TOTAL OF 762 CPSS WERE PLACED IN THE SPINE LEVEL OF C2 TO TH3. THE RADIOLOGICAL ACCURACY OF CPS PLACEMENT WAS EVALUATED USING POSTOPERATIVE CT. ACCURACY OF CPS PLACEMENT USING A PREOPERATIVE 3D CT-BASED NAVIGATION SYSTEM WAS 93.6 % (423 OF 452 SCREWS) IN GRADE 0; THE SCREW WAS COMPLETELY CONTAINED IN THE PEDICLE, AND ACCURACY OF CPS PLACEMENT USING AN INTRAOPERATIVE 3D CT-BASED NAVIGATION SYSTEM WAS A LITTLE BIT IMPROVED TO 97.1%(301 OF 310 SCREWS) IN GRADE 0. CPS MISPLACEMENT (MORE THAN HALF OF SCREW) WAS 3.3 % (15 OF 452 SCREWS) USING A PREOPERATIVE 3D CT-BASED NAVIGATION SYSTEM, AND CPS MISPLACEMENT (MORE THAN HALF OF SCREW) WAS 0.6%(2 OF 310 SCREWS) USING AN INTRAOPERATIVE 3D CT-BASED NAVIGATION SYSTEM. IN TOTAL, 38 SCREWS (5.0 %) WERE FOUND TO PERFORATE THE CORTEX OF PEDICLE, ALTHOUGH ANY NEURAL OR VASCULAR COMPLICATIONS CLOSELY ASSOCIATED WITH CPS PLACEMENT WERE NOT ENCOUNTERED. TWENTY NINE OF 38 SCREWS (76.3 %) WERE FOUND TO PERFORATE LATERALLY, AND SEVEN SCREWS (18.4 %) WERE FOUND TO PERFORATE MEDIALLY. IMAGE-GUIDED CPS PLACEMENT HAS BEEN AN IMPORTANT ADVANCEMENT TO SECURE THE SAFE SURGERY, ALTHOUGH THE USE OF CPS PLACEMENT NEEDS TO BE CAREFULLY DETERMINED BASED ON THE INDIVIDUAL PATHOLOGY. SCREW POSITIONS WERE CLASSIFIED INTO FOUR GRADES: GRADE 0, NO PERFORATION, AND THE SCREW WAS COMPLETELY CONTAINED IN THE PEDICLE; GRADE 1, PERFORATION <2 MM (THAT IS, LESS THAN HALF OF THE SCREW DIAMETER); GRADE 2, PERFORATIONS =2 MM BUT <4MM; AND GRADE 3, PERFORATION =4MM (COMPLETE PERFORATION). A TOTAL OF 452 CPSS WERE PLACED USING A PREOPERATIVE 3D CT-BASED NAVIGATION SYSTEM (FIRST PERIOD OF 2007-2012), AND A TOTAL OF 310 CPSS USING AN INTRAOPERATIVE 3D CTBASED NAVIGATION SYSTEM (SECOND PERIOD OF 2012-2015), SO THAT 762 CPSS WERE PLACED IN THE SPINE LEVEL OF C2 TO TH3. IN THE FIRST PERIOD OF 2007-2012, ACCURACY OF CPS PLACEMENT WAS 93.6 % (423 OF THE 452 SCREWS) IN GRADE 0, 3.1 % (14 OF THE 452 SCREWS) IN GRADE 1, 2.7 % (12 OF THE 452 SCREWS) IN GRADE 2, AND 0.6 % (3 OF THE 452 SCREWS) IN GRADE 3. IN THE SECOND PERIOD OF 2012-2015, ACCURACY OF CPS PLACEMENT WAS 97.1% (301 OF THE 310 SCREWS) IN GRADE 0, 2.3 % (7 OF THE 310 SCREWS) IN GRADE 1, 0.3 % (1 OF THE 310 SCREWS) IN GRADE 2, AND 0.3 % (1 OF THE 310 SCREWS) IN GRADE 3. ACCURACY OF CPS PLACEMENT WAS ALSO ANALYZED BASED ON SPINE LEVEL. SCREW MALPOSITION WAS FOUND 0.9 % (1 OF 114 SCREWS) AT C2, 5.5 % (5 OF 91 SCREWS) AT C3, 5.9%(8 OF 135 SCREWS) AT C4, 4.9%(6 OF 122 SCREWS) AT C5, 3.3%(3 OF 88 SCREWS) AT C6, 10.2%(10 OF 98 SCREWS) AT C7, 5.9 % (4 OF 68 SCREWS) AT T1, 2.9 % (1 OF 34 SCREWS) AT T2, AND 0 % (0 OF 12 SCREWS) AT T3. THE OVERALL RATE OF SCREW MALPOSITION RATE AT C2-C6 (WHERE VAS ARE USUALLY RUNNING IN THE TRANSVERSE FORAMEN) WAS 4.1 % (23 OF 550 SCREWS). ILLUSTRATIVE CASE OF POSTERIOR CERVICAL INSTRUMENTED FIXATION USING CPS WAS PRESENTED IN FIGS. 4 AND 5 IN TOTAL, 38 OF THE 762 SCREWS (5.0 %) WERE FOUND TO PERFORATE THE CORTEX OF PEDICLE IN THE FIRST AND SECOND PERIOD, ALTHOUGH ANY NEURAL OR VASCULAR COMPLICATIONS CLOSELY ASSOCIATED WITH CPS PLACEMENT WERE NOT ENCOUNTERED IN THE PRESENT STUDY. THERE WAS NO CASE OF VERTEBRAL ARTERY INJURY RELATED TO CPS PLACEMENT. TWENTY NINE OF THE 38 SCREWS (76.3 %) WERE FOUND TO PERFORATE LATERALLY, 7 SCREWS (18.4 %) WERE FOUND TO PERFORATE MEDIALLY, AND 2 SCREWS (5.3 %) WERE FOUND TO PERFORATE INFERIORLY. THERE WERE NO SCREWS THAT WERE FOUND TO PERFORATE SUPERIORLY. ACCURACY OF CPS PLACEMENT WAS SUMMARIZED IN TABLE 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483159 STEALTHSTATION TRIA NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) TRIA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other