BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHANTOMMSK HIP

    MDR report key: 9733315 · Received February 19, 2020

    Report

    Report Number
    MW5093112
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Date of Event
    January 15, 2020
    Report Date
    February 14, 2020
    Manufacturer
    ORTHOGRID SYSTEMS, INC.
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SYSTEM FAILURE. TEST DID NOT HAPPEN. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191557 PHANTOMMSK HIP SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ ORTHOGRID SYSTEMS, INC. /PHANTOM MSK 2.4.0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other