BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 12920476 · Received December 2, 2021

    Report

    Report Number
    1723170-2021-02800
    Event Type
    Injury
    Date Received
    December 2, 2021
    Date of Event
    June 12, 2021
    Report Date
    December 2, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE.) EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE.) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE.) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER, THEREFORE IS UNAVAILABLE.) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.) DEVICE MANUFACTURE DATE IS DEPENDENT ON THE DEVICE LOT/SERIAL NUMBER, THEREFORE IS UNAVAILABLE. CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: UNK_OARM_SYS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CITATION: (MASATO TANAKA, HARDIK SUTHAR, YOSHIHIRO FUJIWARA, YOSHIAKI ODA, KOJI UOTANI, SHINYA ARATAKI, TARO YAMAUCHI, HARUO MISAWA.). INTEROPERATIVE O-ARM NAVIGATION GUIDED ANTERIOR CERVICAL SURGERY; A TECHNICAL NOTE AND CASE SERIES. INTERDISCIPLINARY NEUROSURGERY: ADVANCED TECHNIQUES AND CASE MANAGEMENT 26 (2021) (B)(4). HTTPS://DOI.ORG/10.1016/J.INAT.2021.101288 ABSTRACT: BACKGROUND: NAVIGATION SURGERY IS BECOMING VERY POPULAR FOR ANTERIOR CERVICAL SURGERY. HOWEVER, ONE DIFFICULT PROBLEM FOR ANTERIOR CERVICAL SURGERY IS SETTING THE REFERENCE FRAME (RF), DUE TO THE LACK OF RELIABLE STRUCTURES. IF THE RF IS ATTACHED TO THE HEAD HOLDER OR OPERATION TABLE INSTEAD OF THE PATIENT, THE ACCURACY OF NAVIGATION IS NOT GOOD. MATERIALS AND METHODS: THIS RETROSPECTIVE STUDY INCLUDED SIX PATIENTS WHO UNDERWENT ANTERIOR CERVICAL SURGERIES WITH O-ARM NAVIGATION. THE RF WAS ATTACHED TO THE CASPAR RETRACTOR USING A SPECIAL ADAPTOR. PATIENTS COMPRISED THREE MEN AND THREE WOMEN WITH A MEAN AGE OF 62.8 YEARS. ANTERIOR CERVICAL DISCECTOMY AND FUSION WAS PERFORMED IN THREE CASES, AND ANTERIOR CERVICAL CORPECTOMY AND FUSION IN THREE CASES. WE EVALUATED THE ACCURACY OF NAVIGATION, SURGICAL TIME, INTRAOPERATIVE BLOOD LOSS, COMPLICATIONS, BONY FUSION, AND CLINICAL RESULTS. RESULTS: MEAN ACCURACY OF ANTERIOR NAVIGATION WAS 1.1 ± 0.7 MM (RANGE, 0¿2 MM). MEAN SURGICAL TIME AND BLOOD LOSS WERE 166 ± 39 MIN (RANGE, 121¿359 MIN) AND 280 ± 189 ML (RANGE, 50¿600 ML), RESPECTIVELY. COMPLICATIONS COMPRISED ONE CASE OF POSTOPERATIVE C5 PALSY THAT RECOVERED WITHIN 6 MONTHS. MEAN JAPANESE ORTHOPEDIC ASSOCIATION (JOA) RECOVERY RATE WAS 52.4% (RANGE, 20¿100%). ADEQUATE DECOMPRESSION AND SOLID FUSION WERE OBTAINED IN ALL CASES. CONCLUSIONS: INTRAOPERATIVE O-ARM NAVIGATION-GUIDED ANTERIOR CERVICAL DECOMPRESSION AND FUSION IS AN EFFECTIVE TECHNIQUE FOR ACHIEVING PRECISE DECOMPRESSION. THIS NEW NAVIGATION TECHNIQUE PROVIDES EXCELLENT RESULTS FOR SEVERE CERVICAL OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT (OPLL) WITH MINIMUM RISK OF ADVERSE EVENTS FROM INTRAOPERATIVE RADIATION. WE ADVOCATE THE USE OF THIS NOVEL TECHNIQUE IN CASES OF CERVICAL CANAL STENOSIS DUE TO LARGE DISC OSTEOPHYTE COMPLEX AND OPLL, AND ALSO IN CASES OF DISTORTED CERVICAL ANATOMY DUE TO DEFORMITY, TUMOR, OR REVISION SURGERY. REPORTED EVENT: ONE PATIENT EXPERIENCED A POST-OPERATIVE C5 PALSY THAT RECOVERED WITHIN 6 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818144 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention