BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREWS

    MDR report key: 9238868 · Received October 25, 2019

    Report

    Report Number
    1526439-2019-52291
    Event Type
    Injury
    Date Received
    October 25, 2019
    Report Date
    September 17, 2019
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: TIMUR M. URAKOV, MD, KEN HSUAN-KAN CHANG, MD, S. SHELBY BURKS, MD, AND MICHAEL Y. WANG, MD NEUROSURG FOCUS 42 (5):E4, 2017 (USA). THE AIM OF THIS STUDY WAS TO REPORT EVALUATES THE FEASIBILITY OF ROBOT-ASSISTED PEDICLE INSTRUMENTATION IN AN ACADEMIC ENVIRONMENT WITH THE INVOLVEMENT OF RESIDENTS AND FELLOWS. THE FOLLOWING COMPLICATION WAS REPORTED: ONE REPORT OF SCREW DISLODGEMENT. EXPEDIUM AND VIPER PRODUCTS WERE USED AS A PART OF THIS STUDY. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034459 UNKNOWN SCREWS UNKNOWN HWC DEPUY SPINE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other