BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 9268712 · Received November 1, 2019

    Report

    Report Number
    1723170-2019-05442
    Event Type
    Death
    Date Received
    November 1, 2019
    Date of Event
    September 20, 2018
    Report Date
    November 1, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS THE MEAN VALUE OF THE AGE OF THE PATIENT(S) IN THE STUDY. PATIENT GENDER IS THE MAJORITY VALUE OF THE PATIENT(S) IN THE STUDY. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. DEATH DATE IS ESTIMATED AS EVENT DATE AS THE DATE WAS NOT PROVIDED IN THE LITERATURE ARTICLE. EVENT DATE IS THE ACCEPTED DATE OF THE LITERATURE FILE FOR 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. - ATTACHMENT: [BARZILAI_2019.PDF]

    Description of Event or Problem · 1

    CITATION ORI BARZILAI, MD LILY MCLAUGHLIN, BS ERIC LIS, MD ANNE S. REINER, MPH MARK H. BILSKY,MD ILYA LAUFER,MD UTILITY OF CEMENT AUGMENTATION VIA PERCUTANEOUS FENESTRATED PEDICLE SCREWS FOR STABILIZATION OF CANCER-RELATED SPINAL INSTABILITY. OPERATIVE NEUROSURGERY; VOLUME 16, NUMBER 5, MAY 2019 BACKGROUND: CANCER PATIENTS EXPERIENCE PATHOLOGICAL FRACTURES AND THE TYPICAL POOR BONE QUALITY FREQUENTLY COMPLICATES STABILIZATION. METHODS FOR OVERCOMING SCREW FAILURE INCLUDE UTILIZATION OF FENESTRATED SCREWS THAT PERMIT THE INJECTION OF BONE CEMENT INTO THE VERTEBRAL BODY TO AUGMENT FIXATION. OBJECTIVE: TO EVALUATE THE SAFETY AND EFFICACY OF CEMENT AUGMENTATION VIA FENESTRATED SCREWS. METHODS: A RETROSPECTIVE CHART REVIEW OF PATIENTS WITH NEOPLASTIC SPINAL INSTABILITY WHO UNDERWENT PERCUTANEOUS INSTRUMENTED STABILIZATION WITH CEMENT AUGMENTATION USING FENESTRATED PEDICLE SCREWS. PATIENT DEMOGRAPHIC AND TREATMENT DATA AND INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS WERE EVALUATED BY CHART REVIEW AND RADIOGRAPHIC EVALUATION. PROSPECTIVELY COLLECTED PATIENT REPORTED OUTCOMES (PRO) WERE EVALUATED AT SHORT (2-6 MO) AND LONG TERM (6-12 MO). RESULTS: CEMENT AUGMENTATION WAS PERFORMED IN 2016 FENESTRATED PEDICLE SCREWS IN 53 PATIENTS. THREE PATIENTS REQUIRED REOPERATION. ONE PATIENT HAD AN ASYMPTOMATIC SCREW FRACTURE AT 6 MO POSTOPERATIVELY THAT DID NOT REQUIRE INTERVENTION. NO CASES OF LUCENCY AROUND THE PEDICLE SCREWS, ROD FRACTURES, OR CEMENT EXTRAVASATION INTO THE SPINAL CANALWERE OBSERVED. EIGHT CASES OF ASYMPTOMATIC, RADIOGRAPHICALLY-DETECTED VENOUS EXTRAVASATION WERE FOUND. SYSTEMIC COMPLICATIONS INCLUDED A PULMONARY CEMENT EMBOLISM, A LOWER EXTREMITY DEEP VEIN THROMBOSIS, AND A POSTOPERATIVE MORTALITY SECONDARY TO PULMONARY FAILURE FROM WIDESPREAD METASTATIC PULMONARY INFILTRATION. SIGNIFICANT IMPROVEMENT IN PRO MEASURES WAS FOUND IN SHORT AND LONG-TERM ANALYSIS. CONCLUSION: CEMENT AUGMENTATION OF PEDICLE SCREWS IS AN EFFECTIVE METHOD TO ENHANCE THE DURABILITY OF SPINAL CONSTRUCTS IN THE CANCER POPULATION. RISKS INCLUDE CEMENT EXTRAVASATION INTO DRAINING BLOOD REPORTED EVENTS: 1) ONE CASE OF IN-HOUSE MORTALITY WAS DOCUMENTED SECONDARY TO PULMONARY FAILURE FROM WIDESPREAD METASTATIC INFILTRATION OF THE LUNGS WITH NO EVIDENCE OF PE OR OTHER CEMENT RELATED TOXICITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063965 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death