BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREWS

    MDR report key: 7927341 · Received October 2, 2018

    Report

    Report Number
    1526439-2018-50934
    Event Type
    Injury
    Date Received
    October 2, 2018
    Report Date
    September 4, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HWC
    UDI-DI
    (01)UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. 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 SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: INITIAL ACADEMIC EXPERIENCE AND LEARNING CURVE WITH ROBOTIC SPINE INSTRUMENTATION: TIMUR M. URAKOV, MD, KEN HSUAN-KAN CHANG, MD, S. SHELBY BURKS, MD, AND MICHAEL Y. WANG, MD. SUBMITTED JANUARY 3, 2017. ACCEPTED FEBRUARY 17, 2017. N=1 DISLODGED PELVIC SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769024 UNKNOWN SCREWS UNKNOWN HWC MEDOS INTERNATIONAL SàRL CH (01)UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention