BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINEGUARD

    MDR report key: 1953604 · Received January 5, 2011

    Report

    Report Number
    MW5018886
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 4, 2011
    Manufacturer
    SPINEGUARD
    Product Code
    FPP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SPINEGUARD PODIGUARD NOT WORKING - NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINEGUARD SPINEGUARD PODIGUARD TRI TIP FPP SPINEGUARD 10312C0104

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR