BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 13711691 · Received March 9, 2022

    Report

    Report Number
    1723170-2022-00339
    Event Type
    Injury
    Date Received
    March 9, 2022
    Date of Event
    February 10, 2022
    Report Date
    March 11, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY. THIS VALUE REFLECTS THE MEAN AGE OF THE PATIENTS WHO UNDERWENT THE NAVIGATED TLIF AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE MAJORITY GENDER OF THE PATIENTS WHO UNDERWENT THE NAVIGATED TLIF AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE PUBLISHED ONLINE DATE. THE ARTICLE CITATION IS INCLUDED. THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO 510K PROVIDED AS SYSTEM IS UNKNOWN. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    D1: THE NAVIGATION SYSTEM WAS A STEALTHSTATION S7. 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.

    Additional Manufacturer Narrative · 0

    LITERATURE HAS BEEN ATTACHED. 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

    LIU, J. B., WU, J. L., ZUO, R., LI, C. Q., ZHANG, C., <(>&<)>AMP; ZHOU, Y. (2022). DOES MIS-TLIF OR TLIF RESULT IN BETTER PEDICLE SCREW PLACEMENT ACCURACY AND CLINICAL OUTCOMES WITH NAVIGATION GUIDANCE? BMC MUSCULOSKELETAL DISORDERS, 23(1). HTTPS://DOI.ORG/10.1186 /S12891-022-05106-1 SUMMARY: BACKGROUND: ALTHOUGH PREVIOUS STUDIES HAVE SUGGESTED THAT NAVIGATION CAN IMPROVE THE ACCURACY OF PEDICLE SCREW PLACEMENT, FEW STUDIES HAVE COMPARED NAVIGATION-ASSISTED TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AND NAVIGATION-ASSISTED MINIMALLY INVASIVE TLIF (MIS-TLIF). THE ENTRY POINT OF PEDICLE SCREW INSERTION IN NAVIGATION-ASSISTED MIS-TLIF (NM-TLIF) MAY DEVIATE FROM THE PLANNED ENTRY POINT DUE TO AN UNEVEN BONE SURFACE, WHICH MAY RESULT IN MISPLACEMENT. THE PURPOSE OF THIS STUDY WAS TO EXPLORE THE PEDICLE SCREW ACCURACY AND CLINICAL CONSEQUENCES OF MISTLIF AND TLIF, BOTH UNDER O-ARM NAVIGATION, TO DETERMINE WHICH SURGICAL METHOD IS BETTER. METHODS: A RETROSPECTIVE STUDY OF 54 PATIENTS WHO UNDERWENT SINGLE-SEGMENT NM-TLIF OR NAVIGATION-ASSISTED TLIF (N-TLIF) WAS CONDUCTED D. IN ADDITION TO THE PATIENTS¿ DEMOGRAPHIC CHARACTERISTICS, INTRAOPERATIVE INDICATORS AND COMPLICATIONS, THE OSWESTRY DISABILITY INDEX (ODI) AND VISUAL ANALOG SCALE (VAS) SCORE WERE RECORDED AND ANALYZED PREOPERATIVELY AND AT THE 1-, 6-, AND 12-MONTH AND FINAL PO STOPERATIVE FOLLOW-UPS. THE CLINICAL QUALITATIVE ACCURACY AND ABSOLUTE QUANTITATIVE ACCURACY OF PEDICLE SCREW PLACEMENT WERE ASSESSED BY POSTOPERATIVE CT. MULTIFIDUS MUSCLE INJURY WAS EVALUATED BY T2-WEIGHTED MRI. RESULTS: COMPARED WITH N-TLIF, NM-TLIF WAS MORE ADVANTAGEOUS IN TERMS OF THE INCISION LENGTH, INTRAOPERATIVE BLOOD LOSS, DRAINAGE VOLUME, TIME TO AMBULATION, LENGTH OF HOSPITAL STAY, BLOOD TRANSFUSION RATE AND ANALGESIA RATE (P <(><<)> 0.05). THE ODI AND VAS SCORES FOR LOW BACK PAIN WERE BETTER THAN THOSE OF N-TLIF AT 1 MONTH AND 6 MONTHS POSTSURGERY (P <(><<)> 0.05). THERE WAS NO SIGNIFICANT DIFFERENCE IN THE CLINICAL QUALITATIVE SCREW PLACEMENT ACCURACY (97.3% VS. 96.2%, P > 0.05). THE ABSOLUTE QUANTITATIVE ACCURACY RESULTS SHOWED THAT THE AXIAL TRANSLATIONAL ERROR, SAGITTAL TRANSLATIONAL ERROR, AND SAGITTAL ANGLE ERROR IN THE NM-TLIF GROUP WERE SIGNIFICANTLY GREATER THAN THOSE IN THE N-TLIF GROUP (P <(><<)> 0.05). THE MEAN T2-WEIGHTED SIGNAL INTENSITY OF THE MULTIFIDUS MUSCLE IN THE NM-TLIF GROUP WAS SIGNIFICANTLY LOWER THAN THAT IN THE N-TLIF GROUP (P <(><<)> 0.05). CONCLUSIONS: COMPARED WITH N-TLIF, NM-TLIF HAS THE ADVANTAGES OF BEING LESS INVASIVE, YIELDING SIMILAR OR BETTER SCREW PLACEMENT ACCURACY AND ACHIEVING BETTER SYMPTOM RELIEF IN THE MIDTERM POSTOPERATIVE RECOVERY PERIOD. HOWEVER, MORE ATTENTION SHOULD BE GIVEN TO REAL-TIME ADJUSTMENT FOR PEDICLE INSERTION IN NM-TLIF RATHER THAN JUST FOLLOWING THE ENTRY POINT AND TRAJECTORY OF THE INTRAOPERATIVE PLAN. REPORTED EVENT: 54 PATIENTS WITH A HISTOLOGY OF DEGENERATIVE DISEASES UNDERWENT A NAVIGATED TLIF. AMONG THESE PATIENTS THERE WERE FIFTEEN SCREWS PLACED THAT BREACHED THE PEDICLE BY LESS THAN 2MM, AND SEVEN SCREWS THAT BREACHED THE PEDICLE BETWEEN 2 TO 4MM. FOUR PATIENTS UNDERWENT A BLOOD TRANSFUSION. IT WAS ALSO OBSERVED IN THE ONE YEAR POST-OP, THERE WERE PATIENTS WITH FAT INFILTRATION AND MUSCLE ATROPHY. PLEASE SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856378 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention| O