BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 20198959 · Received September 12, 2024

    Report

    Report Number
    3004785967-2024-00547
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    September 1, 2024
    Report Date
    September 12, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A5) PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ESTIMATED ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    VUCICEVIC, R.S., FEDERICO, V., SHAHZAD, H., YAZDANBAKHSH, K., SALAZAR, L., ZAVRAS, A.G., CASTONGUAY, J., BUTLER, A.J., PHILLIPS, F.M., KHAN, S.N., PRICE, R., COLEMAN, M. P226. ADVANCED IMAGING-BASED ACCURACY OF PEDICLE SCREW PLACEMENT USING AN AUGMENTED-REALITY ASSISTED NAVIGATION SYSTEM. THE SPINE JOURNAL, VOLUME 24, ISSUE 9, S175. DOI: 10.1016/J.SPINEE.2024.06.349. BACKGROUND CONTEXT: THE ACCURACY OF PEDICLE SCREW PLACEMENT HAS BEEN FOUND TO IMPROVE WITH THE USE OF NAVIGATION TECHNOLOGY. INTRAOPERATIVE IMAGING DATA ISTYPICALLY PROVIDED TO THE SURGEON VIA AN EXTERNAL SCREEN, REQUIRING THE REMOVAL OF LINE-OF-SIGHT FOCUS FROM THE SURGICAL FIELD. AUGMENTED REALITY (AR) TECHNOLOGY COMBINES NAVIGATION TECHNOLOGY WITH A THREE-DIMENSIONAL ANATOMIC DISPLAY AND PROJECTS DIRECTLY ONTO THE USER¿S RETINA, ALLOWING FOR SIMULTANEOUS INTERPRETATION OF BOTH REAL WORLD AND SIMULATED DATA. PURPOSE: THIS STUDY USED POST-IMPLANTATION ADVANCED IMAGING IN ORDER TO ANALYZE THE POSITION OF PEDICLE SCREWS PLACED USING AR TECHNOLOGY AND REPORTS ON SAFETY AND ACCURACY. STUDY DESIGN/SETTING: N/A PATIENT SAMPLE: N/A OUTCOME MEASURES: N/A METHODS: CASES UTILIZING AR TECHNOLOGY FROM TWO SURGEONS WERE INCLUDED. ALL CASES INCLUDED A POST-INSTRUMENTATION INTRA-OPERATIVE O-ARM SCAN. SURGICAL METRICS INCLUDING SCREW DIMENSIONS, PERCENTAGE OF PEDICLE FILL, FACET AND SUPERIOR END-PLATE VIOLATION, GERTZBEIN-ROBBINS CLASSIFICATION OF PEDICLE BREACH, ANGULAR DEVIATION FROM AN IDEAL PEDICLE SCREW PATH, INCIDENCE OF INTRA-OPERATIVE SCREW REVISION, AND POST OPERATIVE COMPLICATIONS WERE COLLECTED. BOTH PRE-INSTRUMENTATION AND POST-INSTRUMENTATION IMAGES WERE USED TO COLLECT THE REQUIRED DATA POINTS. PEDICLE WIDTH WAS DEFINED AS THE THICKEST PORTION OF THE PEDICLE MEASURING FROM OUTER CORTEX TO OUTER CORTEX. THE "IDEAL" SCREW PATH WAS DEFINED AS A LINE BISECTING THE PREVIOUSLY DEFINED PEDICLE WIDTH IN A PERPENDICULAR FASHION, THUS ENSURING THE SCREW WOULD BE WITHIN THE THICKEST PORTION OF THE PEDICLE, WHILE ALSO AVOIDING CONTACT WITH THE FACET JOINT. THE DEVIATION FROM THIS IDEAL PATH WAS OBTAINED BY SUBTRACTING THE ANGULAR MEASUREMENT OF THE IDEAL PATH FROM THE ANGLE OF THE FINAL INSTRUMENTED SCREW PATH. A POSITIVE DIFFERENCE INDICATES DEVIATION MEDIAL TO THE IDEAL PATH. OPERATIVE REPORTS WERE REVIEWED FOR SCREW DIMENSIONS. RESULTS: A TOTAL OF 129 PEDICLE SCREWS WERE INCLUDED, OF WHICH 31% WERE PLACED IN THORACIC, 53% WERE PLACED IN LUMBAR, AND 16% IN SACRAL REGION. THE MEAN PEDICLE FILL WAS 69.82§47.48%. THERE WAS 0% VIOLATION OF NON-FUSION FACETS, BUT 3.9% OF THE TIME A SCREW VIOLATED A FUSION FACET. COMPLETE INTRAPEDICULAR SCREW PLACEMENT WAS ACCOMPLISHED IN 80.6% OF SCREWS, FOLLOWED BY 6.2% CLASSIFIED AS GRADE B (<(><<)> 2MM), 9.3% AS GRADE C (2 <(><<)> 4 MM), AND 3.9% AS GRADE D (4 <(><<)> 6 MM). THIS EQUATED TO A PEDICLE BREACH OCCURRING IN 18.6% OF ALL SCREWS, WITH 32% BREACHING MEDIALLY, 60% LATERALLY, AND 8% BREACHING BOTH MEDIALLY AND LATERALLY. THORACIC, LUMBAR, AND SACRAL SCREWS SHOWED BREACHES OF 27.5%, 18.8%, AND 0%, RESPECTIVELY (P-VALUE = 0.036). WE DETERMINED A 1.55§5.28 DEGREE DEVIATION FROM THE IDEAL PATH ACROSS ALL SCREWS. THORACIC, LUMBAR, AND SACRAL SCREWS DEVIATED -.35§.73 DEGREES, 2.84§.56 DEGREES, AND .88§1.59, RESPECTIVELY (P-VALUE = 0.007). THERE WERE NO SCREWS REVISED INTRAOPERATIVELY OR POSTOPERATIVELY, AND NO NEUROLOGIC COMPLICATIONS. CONCLUSIONS: THE APPLICATIONS OF AR FOR PROGRESSING SURGICAL TECHNIQUE ARE RAPIDLY DEVELOPING. THE INITIAL RADIOGRAPHIC CHARACTERISTICS OF PEDICLE SCREWS PLACED USING A NOVEL AR SYSTEM ARE PRESENTED, INDICATING PROMISING POTENTIAL FOR A HIGH STANDARD OF ACCURACY AND EFFICIENCY. FURTHER LARGE SCALE STUDIESINVOLVING COMPARISON OF OUTCOMES BETWEEN AUGMENTED REALITY AND STANDARD MIS TECHNIQUES ARE WARRANTED. FDA DEVICE/DRUG STATUS: THIS ABSTRACT DOES NOT DISCUSS OR INCLUDE ANY APPLICABLE DEVICES OR DRUGS. REPORTED EVENTS: 3.9% OF THE TIME A SCREW VIOLATED A FUSION FACET. 6.2% CLASSIFIED AS GRADE B (<(><<)> 2MM), 9.3% AS GRADE C (2 <(><<)> 4 MM), AND 3.9% AS GRADE D (4 <(><<)> 6 MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473664 O-ARM IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M OXO MEDTRONIC NAVIGATION, INC (LITTLETON) UNK_OARM_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown