BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 13079393 · Received December 23, 2021

    Report

    Report Number
    1723170-2021-02959
    Event Type
    Injury
    Date Received
    December 23, 2021
    Date of Event
    May 23, 2021
    Report Date
    December 23, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    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 PATIENTS IN THE STUDY. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ONLINE PUBLICATION DATE OF THE ARTICLE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. 510(K) IS DEPENDENT ON THE DEVICE MODEL NUMBER. THEREFORE, IS UNAVAILABLE. DEVICE MANUFACTURE DATE IS DEPENDENT ON THE DEVICE LOT/SERIAL NUMBER, THEREFORE IS UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: UNK_OARM_SYS, SERIAL/LOT #: UNK. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CITATION: ROBERT Y. NORTH, MICHAEL J. STRONG, TIMOTHY J. YEE, OSAMA N. KASHLAN, MARK E. OPPENLANDER, PAUL PARK. NAVIGATION AND ROBOTIC-ASSISTED SINGLE-POSITION PRONE LATERAL LUMBAR INTERBODY FUSION: TECHNIQUE, FEASIBILITY, SAFETY, AND CASE SERIES. WORLD NEUROSURG. (2021) 15 2:221-230. HTTPS://DOI.ORG/10.1016/J.WNEU.2021.05.097 ABSTRACT: -BACKGROUND: SINGLE-POSITION PRONE LATERAL INTERBODY FUSION IS A RECENTLY INTRODUCED TECHNICAL MODIFICATION OF THE MINIMALLY INVASIVE RETROPERITONEAL TRANSPSOAS APPROACH FOR LATERAL LUMBAR INTERBODY FUSION (LLIF). SEVERAL TECHNICAL DESCRIPTIONS OF SINGLE-POSITION PRONE LLIF HAVE BEEN PUBLISHED WITH TRADITIONAL FLUOROSCOPY FOR GUIDANCE. HOWEVER, THERE HAS BEEN NO INVESTIGATION OF EITHER THREEDIMENSIONAL COMPUTED TOMOGRAPHYEBASED NAVIGATION FOR PRONE LLIF OR INTEGRATION WITH ROBOTIC ASSISTANCE PLATFORMS WITH THE PRONE LATERAL TECHNIQUE. THIS STUDY EVALUATED THE FEASIBILITY AND SAFETY OF SPINAL NAVIGATION AND ROBOTIC ASSISTANCE FOR SINGLE-POSITION PRONE LLIF. - METHODS: RETROSPECTIVE REVIEW OF MEDICAL RECORDS AND A PROSPECTIVELY ACQUIRED DATABASE FOR A SINGLE CENTER WAS PERFORMED TO EXAMINE IMMEDIATE AND 30-DAY CLINICAL AND RADIOGRAPHIC OUTCOMES FOR CONSECUTIVE PATIENTS UNDERGOING SINGLE-POSITION PRONE LLIF WITH SPINAL NAVIGATION AND/OR ROBOTIC ASSISTANCE. - RESULTS: NINE PATIENTS WERE TREATED, 4 WOMEN AND 5 MEN. MEAN AGE WAS 65.4 YEARS (RANGE, 46E75 YEARS), AND BODY MASS INDEX WAS 30.2 KG/M2 (RANGE, 24E38 KG/M2). THE MOST COMMON SURGICAL INDICATION WAS ADJACENT SEGMENT DISEASE (44.4%), FOLLOWED BY PSEUDARTHROSIS (22.2%), SPONDYLOLISTHESIS (11.1%), DEGENERATIVE DISC DISEASE (11.1%), AND RECURRENT STENOSIS (11.1%). POSTOPERATIVE APPROACH-RELATED COMPLICATIONS INCLUDED PAIN-LIMITED BILATERAL HIP FLEXOR WEAKNESS (4/5) AND PAIN-LIMITED LEFT KNEE EXTENSION WEAKNESS (4/5) IN 1 PATIENT (11.1%) AND RIGHT LATERAL THIGH NUMBNESS AND DYSESTHESIA IN 1 PATIENT (11.1%). ALL CAGES WERE PLACED WITHIN QUARTERS 2E3, SIGNIFYING THE MIDDLE PORTION OF THE DISC SPACE. THERE WERE NO INSTANCES OF MISGUIDANCE BY NAVIGATION. CONCLUSIONS: INTEGRATION OF SPINAL NAVIGATION AND ROBOTIC ASSISTANCE APPEARS FEASIBLE, ACCURATE, AND SAFE AS AN ALTERNATIVE REPORTED EVENTS: A (B)(6) FEMALE PATIENT EXPERIENCED BILATERAL HIP FLEXION AND LEFT KNEE EXTENSION WEAKLESS, PAIN LIMITED (4/5). A (B)(6) FEMALE PATIENT EXPERIENCED RIGHT ANTEROLATERAL THIGH NUMBNESS AND DYSTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977175 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention