BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 19929133 · Received August 7, 2024

    Report

    Report Number
    3004785967-2024-00468
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    June 12, 2024
    Report Date
    August 7, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. 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

    SRINIVASA, V., THIRUGNANAM, B., KANHANGAD, M.P., SONI, A., KASHYAP, A., VIDYADHARA, A., RAO, S.K. FLATTENING THE LEARNING CURVE ¿ EARLY EXPERIENCE OF ROBOTIC-ASSISTED PEDICLE SCREW PLACEMENT IN SPINE SURGERY. JOURNAL OF ORTHOPAEDICS 57 (2024) 49¿54 HTTPS://DOI.OR G/10.1016/J.JOR.2024.06.011 AIMS AND OBJECTIVES: TO DETERMINE ACCURACY OF PEDICLE SCREWS PLACED BY FREEHAND, FLUOROSCOPY-ASSISTANCE AND ROBOTIC-ASSISTANCE WITH INTRAOPERATIVE IMAGE ACQUISITION, AND DETERMINE THE PRESENCE OF LEARNING CURVE IN ROBOTIC SPINE SURGERY IN A PROSPECTIVE SINGLE CENTRE STUDY. MATERIALS AND METHODS: IN A PROSPECTIVE STUDY, A TOTAL OF 1120 PEDICLE SCREWS WERE PLACED IN FREEHAND GROUP (N = 175), 1250 SCREWS WERE PLACED IN FLUOROSCOPYASSISTED GROUP (N = 172), AND 1225 SCREWS WERE INSERTED IN ROBOTIC-ASSISTED GROUP(N = 180). SURGICAL PARAMETERS AND SCREW ACCURACY WERE ANALYZED BETWEEN THE THREE GROUPS. THE PREOPERATIVE PLAN WAS OVERLAPPED WITH POST OPERATIVE O-ARM SCAN TO DETERMINE IF THE SCREWS WERE EXECUTED AS PLANNED. RESULTS: THE FREQUENCY OF CLINICALLY ACCEPTABLE SCREW PLACEMENT (GERTZBEIN AND ROBBINS GRADE A, B) IN THE FREEHAND, FLUOROSCOPY-ASSI STED, AND ROBOTIC-ASSISTED GROUPS WERE 97.7 %, 98.6 %, AND 99.34 % RESPECTIVELY. HIGHER PEDICLE SCREW ACCURACY, AND LOWER BLOOD LOSS WERE SEEN WITH ROBOTIC ASSISTANCE. THERE WAS NO SIGNIFICANT DIFFERENCE IN THESE PARAMETERS BETWEEN SURGERIES COMMENCING BEFORE AND AFTER 2 P.M. WE FOUND NO STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN THE PLANNED AND EXECUTED SCREW TRAJECTORIES IN ROBOTIC ASSISTED GROUP IRRESPECTIVE OF SURGICAL EXPERIENCE. CONCLUSION: THE THIRD-GENERATION ROBOTIC-ASSISTED PEDICLE SCREW PLACEMENT SYSTEM, USED IN CONJUNCTION WITH INTRAOPERATIVE 3D O-ARM I MAGING, CONSISTENTLY LOWERED BLOOD LOSS AND INCREASED ACCURACY OF PEDICLE SCREW PLACEMENT IN THE THORACOLUMBAR SPINE. IT ALSO HAS EASY ADAPTABILITY INTO SPINE PRACTICE WITH MINIMAL LEARNING CURVE. REPORTABLE EVENTS: A TOTAL OF 52 PEDICAL BREACHES REQUIRING REVISION A TOTAL OF 20 POST OPERATIVE WOUND INFECTION ONE PATIENT EXPERIENCED CAUDA EQUINA SYNDROME FROM AN EPIDURAL HEMATOMA SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560385 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 49 YR Female Required Intervention