BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 10831372 · Received November 12, 2020

    Report

    Report Number
    1723170-2020-02976
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    January 24, 2015
    Report Date
    November 12, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 ACCEPTED DATE OF THE PUBLICATION. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. 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 · 1

    CITATION: R. ANDREW GLENNIE, NICOLAS DEA, BRIAN K. KWON, JOHN T. STREET. EARLY CLINICAL RESULTS WITH CORTICALLY BASED PEDICLE SCREW TRAJECTORY FOR FUSION OF THE DEGENERATIVE LUMBAR SPINE. JOURNAL OF CLINICAL NEUROSCIENCE 22 (2015)972-975. DOI.ORG/10.1016/J.JOCN.2015.01.010 ABSTRACT: THIS STUDY REVIEWS THE OUTCOMES AND REVISION RATES OF DEGENERATIVE LUMBAR FUSION SURGERY USING CORTICAL TRAJECTORY PEDICLE SCREWS IN LIEU OF TRADITIONAL PEDICLE SCREW INSTRUMENTATION. PEDICLE SCREW FIXATION CAN BE A CHALLENGE IN PATIENTS WITH LOW BONE MINERAL DENSITY. WIDE POSTERIOR APPROACHES TO THE LUMBAR SPINE EXPOSING LATERAL TO THE FACET JOINTS AND ONTO TRANSVERSE PROCESSES CAUSES AN ADDITIONAL DEGREE OF MUSCULAR DAMAGE AND BLOOD LOSS NOT PRESENT WITH A SIMPLE LAMINECTOMY. A CORTICAL BONE TRAJECTORY PEDICLE SCREW HAS BEEN PROPOSED AS AN ALTERNATIVE TO PREVENT SCREW PULLOUT AND DECREASE THE MORBIDITY ASSOCIATED WITH THE WIDE POSTERIOR APPROACH TO THE SPINE. WE PRESENT A SERIES OF EIGHT CONSECUTIVE PATIENTS USING A CORTICAL BONE TRAJECTORY INSTEAD OF TRADITIONAL PEDICLE SCREW FIXATION FOR DEGENERATIVE CONDITIONS OF THE LUMBAR SPINE. A RETROSPECTIVE REVIEW OF OUR INSTITUTIONAL REGISTRY DATA IDENTIFIED EIGHT PATIENTS WHO HAD CORTICAL SCREWS PLACED WITH THE ASSISTANCE OF O-ARM STEALTH NAVIGATION (MEDTRONIC SOFAMOR DANEK, MEMPHIS, TN, USA) FROM 2010¿2013. WE ANALYZED THE NEED FOR REVISION, THE MAINTENANCE OF REDUCTION AND THE INCIDENCE OF SCREW PULLOUT OR BREAKAGE. OUR REVIEW DEMONSTRATED THAT TWO OF EIGHT PATIENTS WERE REVISED AT AN AVERAGE OF 12 MONTHS. THE REASONS FOR THESE REVISIONS WERE PSEUD ARTHROSIS AND CAUDAL ADJACENT SEGMENT FAILURE. ALL PATIENTS WHO WERE REVISED HAD FRANK SCREW LOOSENING. WE PRESENT EARLY CLINICAL RESULTS OF A NEW TECHNIQUE THAT HAS BEEN SHOWN TO HAVE A BETTER FIXATION PROFILE IN LABORATORY TESTING. OUR LESS THAN FAVORABLE EARLY CLINICAL RESULTS SHOULD BE INTERPRETED WITH CAUTION AND HIGHLIGHT IMPORTANT TECHNICAL ISSUES WHICH SHOULD BE CONSIDERED. REPORTED EVENTS: 64 YR MALE HAD SCREWS REVISED 12 MONTHS AFTER THE OPERATION AS BACK PAIN WAS NOTED. 82 YR FEMALE HAD SCREWS REVISED 12 MONTHS AFTER THE OPERATION AS BACK PAIN AND PSEUDARTHROSIS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295268 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention