BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 19699291 · Received July 9, 2024

    Report

    Report Number
    1723170-2024-01648
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 30, 2023
    Report Date
    July 9, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3) EVENT DATE IS THE ACCEPTED 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

    SAKAI, D., SCHOL, J., KAWACHI, A., SAKO, K., HIYAMA, A., KATOH, H., SATO, M., WATANABE, M. ADOLESCENT IDIOPATHIC SCOLIOTIC DEFORMITY CORRECTION SURGERY ASSISTED BY SMART GLASSES CAN ENHANCE CORRECTION OUTCOMES AND ACCURACY AND ALSO IMPROVE SURGEON FATIGUE. WORLD NEUROSURG. (2023) 178:E96-E103. HTTPS://DOI.ORG/10.1016/J.WNEU.2023.06.144 - OBJECTIVE: AUGMENTED REALITY (AR) IS BECOMING MORE COMMON AND SLOWLY BEING INTEGRATED INTO THE SURGICAL FIELD. WITH THE CONTINUOUS PROGRESSION OF NAVIGATION AND VISU ALIZATION TECHNIQUES, AR HAS GREAT POTENTIAL TO IMPROVE SURGICAL QUALITY AND SAFETY. NEVERTHELESS, THE EFFECTS OF AR ON SURGICAL OUTCOMES AND SURGEONS¿ WELL-BEING REMAINS POORLY STUDIED. THE PRESENT PROSPECTIVE CONTROLLED STUDY AIMS TO ASSESS THE EFFECT OF SURGERY ASSISTED WITH AR SMART GLASSES ON ADOLESCENT IDIOPATHIC SCOLIOSIS (AIS) DEFORMITY CORRECTION OUTCOMES AND SURGEON FATIGUE. - METHODS: AIS PATIENTS SCHEDULED FOR SURGICAL DEFOR MITY CORRECTION WERE PROSPECTIVELY RECRUITED AND ASSIGNED TO STANDARD OR AR-SUPPORTED SURGERY, USING LIGHTWEIGHT AR SMART GLASSES. THE DEMOGRAPHIC AND CLINICAL FEATURES WERE RECORDED. THE PRE- AND POSTOPERATIVE SPINAL FEATURES, OPERATIVE TIME, AND BLOOD LOSS WERE RECORDED AND COMPARED. FINALLY, THE PARTICIPATING SURGEONS WERE ASKED TO COMPLETE A QUESTIONNAIRE (E.G., VISUAL ANALOG SCALE FOR FATIGUE) TO COMPARE THE EFFECTS OF AR ON THEIR WELL-BEING. - RESULTS: OUR RESULTS HAVE SHOWN ENHANCED SPINAL DEFORMITY CORRECTIONS WITH COBB ANGLE (L35.7 VS. L46.9 ), THORACIC KYPHOSIS (8.1 VS. 11.6 ), AND VERTEBRAL ROTATION (L9.3 VS. L13.8 ) CHANGES FAVORING AR-SUPPORTED SURGERY. MOREOVER, AR RESULTED IN SIGNIFICANTLY LOWER VIOLATION RATES PER PATIENT (7.5% VS. 6.6%; P [ 0.023). FINALLY, THE VISUAL ANALOG SCALE FOR FATIGUE SCORES CONSISTENTLY SHOWED A SIGNIFICANT REDUCTION IN FATIGUE (5.7 1.7 VS. 3.3 1.2; P <(><<)> 0.001) AND OTHER FATIGUE CLASSIFIERS FOR THE SURGEONS AFTER AR-SUPPORTED SURGERY. - -CONCLUSIONS: OUR CONTROLLED STUDY HAS HIGHLIGHTED THE ENHANCED SPINAL CORRECTION RATES IN AR-SUPPORTED SURGERY AND ALSO IMPROVED SURGEONS¿ WELL-BEING AND FATIGUE. THESE RESULTS ENDORSE THE ADAPTATION OF AR TECHNIQUES TO SUPPORT AIS SURGICAL CORRECTION. REPORTABLE EVENTS: SPECIFICALLY, OF THE 364 PEDICLE SCREW PLACEMENTS IN THE STANDARD GROUP, 27 (7.4%) WERE CLASSIFIED AS VIOLATIONS. IN CONTRAST, FOR THE AR-S COHORT, 24 OF 427 PEDICLE SCREW INSERTIONS (5.6%) WERE CLASSIFIED AS VIOLATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209484 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown