BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 18101879 · Received November 9, 2023

    Report

    Report Number
    1723170-2023-02208
    Event Type
    Malfunction
    Date Received
    November 9, 2023
    Date of Event
    September 12, 2023
    Report Date
    November 9, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    HADGAONKAR, S., GUPTA, A., AIYER, S., BHILARE, P., SANCHETI, P. LEARNING CURVE ACROSS 2000 THORACOLUMBAR PEDICLE SCREW PLACEMENTS USING O-ARM NAVIGATION: TECHNICAL DIFFICULTIES AND THEIR SOLUTIONS. EUROPEAN SPINE JOURNAL. HTTPS://DOI.ORG/10.1007/S00586-023-07922-Y. INTRODUCTION: INSTRUMENTATION USING THE INTRAOPERATIVE O-ARM NAVIGATION TECHNIQUE APPEARS SAFER THAN ITS PREDECESSOR TECH-NIQUES. HOWEVER, ONLY A HANDFUL OF SURGEONS OFTEN USED NAVIGATION DURING SPINAL SURGERIES. TOO MANY OPERATIVE GLITCHES AND UNRELIABLE NAVIGATION ACCURACY WERE THE IMPORTANT REASONS CITED EVEN BY EXPERIENCED SURGEONS FOR NOT USING SPINAL NAVIGATION. WE HAVE STUDIED THE ACCURACY OF PEDICLE SCREW PLACEMENT DURING THE LEARNING CURVE AND BEYOND IT. WE HAVE ALSO DISCUSSED IN DETAIL THE INTRICACIES OF THE TECHNIQUE AND SOLUTIONS TO THE DIFFICULTIES ENCOUNTERED USING SPINAL NAVIGATION. MATERIALS AND METHODS A TOTAL OF 2000 THORACOLUMBAR PEDICLE SCREWS HAVE BEEN PLACED IN THE 324 SPINE SURGERIES MEETING THE INCLUSION AND EXCLUSION CRITERIA INCLUDED IN THIS RETROSPECTIVE STUDY. WE HAVE DIVIDED 2000 PEDICLE SCREW PLACEMENTS INTO CONSECUTIVE GROUPS OF 200 EACH. WE HAVE COMPARED THESE GROUPS FOR THE ACCURACY OF SCREW PLACEMENT WITH THE SURGEON¿S EXPERIENCE. RESULTS THE ACCURACY OF PEDICLE SCREW PLACEMENT USING THE ¿IN-VERSUS-OUT¿ GRADING SYSTEM IN GROUP 1 WAS 85.5% WHICH SIGNIFICANTLY INCREASED IN GROUP 2 TO 93.5% (P-VALUE: 0.0099), AND THEREAFTER, THERE WAS A NONSIGNIFICANT INCREASE IN SUBSEQUENT GROUPS WITH THE GRAPH ACHIEVING THE SHAPE OF A PLATEAU. CONCLUSION SURGEONS SHOULD LEARN THE CORRECT PRINCIPLES OF THE TECHNIQUE OF O-ARM NAVIGATION TO PREVENT THE LOSS OF ACCU-RACY AND PLACE PEDICLE SCREWS WITH HIGH ACCURACY. THERE IS A LEARNING CURVE OF AROUND 30¿35 SURGERIES OR 200 PEDICLE SCREW PLACEMENTS TO ACCLIMATIZE WITH THE TECHNIQUE OF O-ARM NAVIGATION AND LEARN ITS PRINCIPLES. REPORTABLE EVENTS 13 INCIDENCES WHERE THE INTRAOPERATIVE LOSS OF ACCURACY OF O-ARM NAVIGATION WAS RECOGNIZED AND LOW-DOSE CT SCAN WAS REPEATED, AND THE PROCESS OF REGISTRATION WAS DONE AGAIN 47 NON-ACCEPTABLE SCREW PLACEMENTS IN 40 CASES WHILE THERE WERE 3 CASES WHERE THERE WERE BOTH INTRAOPERATIVE LOSS OF ACCURACY OF O-ARM NAVIGATION AND NON-ACCEPTABLE SCREW PLACEMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110685 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown