BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 16160518 · Received January 13, 2023

    Report

    Report Number
    1723170-2023-00060
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    February 21, 2022
    Report Date
    January 13, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ONLINE ACCEPTED DATE OF THE LITERATURE ARTICLE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    NIE, J.Z., WEBER, M.W., REVELT, N.J., NORDMANN, N.J., WATSON, V.L., NIE, J.W., MENEZES, S.A., DELFINO, K., COZZENS, J.W., ESPINOSA, J.A., AMIN, D., ACAKPO-SATCHIVI, L. COMPARISON OF USING INTRAOPERATIVE COMPUTED TOMOGRAPHYEBASED 3-DIMENSIONAL NAVIGATION AND FLUOROSCOPY IN ANTERIOR CERVICAL DISKECTOMY AND FUSION FOR CERVICAL SPONDYLOSIS. WORLD NEUROSURG. 2022. 161 (E740-E747). HTTPS://DOI.ORG /10.1016/J.WNEU.2022.02.089 - OBJECTIVE: ANTERIOR CERVICAL DISKECTOMY AND FUSION (ACDF) IS A HIGHLY SUCCESSFUL PROCEDURE TO TREAT SPINAL CORD OR NERVE ROOT COMPRESSION; HOWEVER, COMPLICATIONS CAN STILL OCCUR. WITH ADVANCEMENTS IN IMAGING, 3-DIMENSIONAL (3D) RECONSTRUCTION ALLOWS REAL-TIME INSTRUMENT TRACKING IN A SURGICAL FIELD RELATIVE TO THE PATIENT¿S ANATOMY. HERE, WE COMPARE PLATE POSITIONING AND SHORT-TERM OUTCOMES WHEN USING 3D NAVIGATION TO FLUOROSCOPY IN ACDF FOR DEGENERATIVE SPINE DISEASE. - METHODS: ALL ACDFS FOR CERVICAL SPONDYLOSIS PERFORMED BY 6 SURGEONS AT A SINGLE CENTER BETWEEN 2010 AND 2018 WERE INCLUDED. ACDFS WERE DIVIDED INTO THOSE PERFORMED USING 3D NAVIGATION OR FLUOROSCOPY. RECORDS WERE ASSESSED FOR PATIENT DEMOGRAPHICS, AMERICAN SOCIETY OF ANESTHESIOLOGY SCORE, NUMBER OF OPERATED INTERSPACES, OPERATIVE TIME, LENGTH OF STAY, PERIOPERATIVE COMPLICATIONS, AND 90-DAY READMISSIONS. POSTOPERATIVE IMAGES WERE REVIEWED FOR LATERAL AND ANGULAR PLATE DEVIATIONS. - RESULTS: A TOTAL OF 193 ACDFS PERFORMED WITH 3D NAVIGATION AND 728 PERFORMED WITH FLUOROSCOPY WERE INCLUDED. AFTER CONTROLLING FOR DEMOGRAPHICS AND SURGICAL CHARACTERISTICS, USING 3D NAVIGATION WAS ASSOCIATED WITH LESS LATERAL PLATE DEVIATION (P [ 0.048) AND LONGER OPERATIVE TIMES PER INTERSPACE (P <(><<)> 0.001) BUT WAS NOT ASSOCIATED WITH ANGULAR PLATE DEVIATION (P [ 0.724), LENGTH OF STAY (P [ 0.393), PERIOPERATIVE COMPLICATIONS (P [ 0.844), AND 90-DAY READMISSIONS (P [ 0.539). - CONCLUSIONS: USING 3D NAVIGATION IN ACDF FOR DEGENERATIVE DISEASE IS ASSOCIATED WITH SLIGHTLY MORE MIDLINE PLATE POSITIONING AND COMPARABLE SHORT-TERM OUTCOMES AS USING FLUOROSCOPY AND CAN BE A SUITABLE ALTERNATIVE. ADVANTAGES OF USING THIS TECHNOLOGY, SUCH AS IMPROVED VISUALIZATION OF ANATOMY, SHOULD BE WEIGHED AGAINST DISADVANTAGES, SUCH AS INCREASED OPERATIVE TIME, ON A PER-PATIENT BASIS. REPORTED EVENTS: PATIENTS WITH 90-DAY READMISSION: 4 PATIENTS WITH PAIN 2 PATIENTS WITH NEUROLOGIC DEFICIT 3 PATIENTS WITH SURGICAL SITE INFECTION 1 PATIENT WITH WOUND DEHISCENCE 5 PATIENTS WITH HARDWARE FAILURE 4 PATIENTS WITH DYSPHAGIA 1 PATIENT WITH EPIDURAL ABSCESS 2 PATIENTS WITH A HEMATOMA 1 PATIENT WITH AN INFECTION NOT ON THE SURGICAL SITE 3 PATIENTS WITH WEAKNESS 1 PATIENT WITH ASPIRATION 1 PATIENT WITH URINARY RETENTION 3 PATIENTS WITH CARDIAC PROBLEMS 2 PATIENTS WITH PULMONARY PROBLEMS 2 PATIENTS WITH GASTROINTESTINAL PROBLEMS 2 PATIENTS WITH PSYCHIATRIC PROBLEMS 1 PATIENTS WITH TRAUMA SEE ATTACHED LITERATURE ARTICLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963734 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention