BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 7281950 · Received February 20, 2018

    Report

    Report Number
    7281950
    Event Type
    Malfunction
    Date Received
    February 20, 2018
    Date of Event
    February 3, 2018
    Report Date
    February 8, 2018
    Manufacturer
    MIZUHO AMERICA, INC.
    Product Code
    HBM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS IN PLACE WITH PINS HOLDING THE PATIENT'S HEAD. THE SUPPORTING SCREW BROKE AND PROVIDER SUPPORTED PATIENT'S HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124875 UNKNOWN HEADREST, NEUROSURGICAL HBM MIZUHO AMERICA, INC. NP1965

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR OSI TABLE AND HEAD CLAMP