BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 9088269 · Received September 19, 2019

    Report

    Report Number
    1723170-2019-04938
    Event Type
    Injury
    Date Received
    September 19, 2019
    Date of Event
    November 7, 2018
    Report Date
    September 19, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ARTICLE. THIS VALUE IS THE MEAN AGE OF THE PATIENTS WHO UNDERWENT NAVIGATION SYSTEM-ASSISTED MINIMALLY INVASIVE DLIF IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS WHO UNDERWENT NAVIGATION SYSTEM-ASSISTED MINIMALLY INVASIVE DLIF IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. ARTICLE CITATION IS INCLUDED. SYSTEM PRODUCT NUMBER AND SERIAL NUMBER NOT PROVIDED IN JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO 510K PROVIDED AS SYSTEM IS UNKNOWN. NO EVALUATION WAS PERFORMED AS THIS EVENT WAS REPORTED IN LITERATURE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: JIANZHONG JIANG, BS, FENGPING GAN, MS, HAITAO TAN, MD, ZHAOLIN XIE, BS, XIANG LUO, MS, GUOXIU HUANG, MS, YIN LI, MS, SHENGBIN HUANG, MS, EFFECT OF COMPUTER NAVIGATION-ASSISTED MINIMALLY INVASIVE DIRECT LATERAL INTERBODY FUSION IN THE TREATMENT OF PATIENTS WITH LUMBAR TUBERCULOSIS, MEDICINE (2018) 97:48, HTTP://DX.DOI.ORG/10.1097/MD.0000000000013484. SUMMARY: THE BENEFITS OF NAVIGATION-ASSISTED TECHNOLOGIES ARE NOT ENTIRELY UNDERSTOOD. THEREFORE, THIS STUDY AIMED TO EXAMINE THE OUTCOMES OF PATIENTS WITH LUMBAR TUBERCULOSIS WHO RECEIVED COMPUTER NAVIGATION-ASSISTED MINIMALLY INVASIVE DIRECT LATERAL INTERBODY FUSION (DLIF). THIS WAS A (B)(6) STUDY OF 33 PATIENTS WITH LUMBAR TUBERCULOSIS WHO UNDERWENT MINIMALLY INVASIVE DLIF AT THE DEPARTMENT OF SPINE AND ORTHOPEDICS OF GUIGANG PEOPLE¿S HOSPITAL (GUANGXI, CHINA) BETWEEN (B)(6) 2015 AND (B)(6) 2016. THE PATIENTS WERE P ATHOLOGICALLY DIAGNOSED AS LUMBAR TUBERCULOSIS AND GROUPED INTO THE NAVIGATION-ASSISTED FLUOROSCOPY (NAV; N = 18) AND NON-NAVIGATION-ASSISTED FLUOROSCOPY (NON-NAV; N = 15) GROUPS. X-RAY EXPOSURE AND OPERATION TIMES WERE ASSESSED IN ALL PATIENTS. ALL SURGICAL PROCEDURES WERE SUCCESSFULLY COMPLETED. NO CASE WAS CONVERTED INTO OPEN SURGERY. THE NAV GROUP HAD LONGER SURGICAL PREPARATION TIME BUT SHORTER OPERATION TIME COMPARED WITH THE NON-NAV GROUP (BOTH P <(><<)>.01). TOTAL OPERATION TIME SHOWED NO SIGNIFICANT DIFFERENCE BETWEEN THE 2 GROUPS (P =.1). THE TIME OF RADIATION EXPOSURE IN THE NON-NAV GROUP WAS LONGER COMPARED WITH THAT OF THE NAV GROUP (53.2 ± 9.9 VS 13.5 ± 2.6 S; P <(><<)>.01). THERE WERE NO SIGNIFICANT DIFFERENCES REGARDING INTRAOPERATIVE BLOOD LOSS, POSTOPERATIVE DRAINAGE VOLUME, LENGTH OF HOSPITAL STAY, BONE FUSION AND COMPLICATIONS BETWEEN THE 2 GROUPS (ALL P >.05). COMPUTER NAVIGATION-ASSISTED MINIMALLY INVASIVE DLIF COULD SIGNIFICANTLY REDUCE INTRAOPERATIVE RADIATION EXPOSURE, WITH NO INCREASE IN TOTAL OPERATION TIME. REPORTED EVENTS: TWO PATIENTS HAD ANTERIOR NUMBNESS OF THE IPSILATERAL THIGH AND FIVE PATIENTS FELT WEAK WHEN FLEXING THE HIP. THESE PATIENTS RECEIVED PHYSIOTHERAPY, ACUPUNCTURE, AND NEUROTROPHIC DRUGS, AND RECOVERED WITHIN 1 TO 3 MONTHS OF THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880807 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention