BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIGUARD

    MDR report key: 5922392 · Received September 1, 2016

    Report

    Report Number
    5922392
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Date of Event
    August 10, 2016
    Report Date
    August 22, 2016
    Manufacturer
    ORGENIX, LLC
    Product Code
    PDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SPINE GUARD PEDICLE FAILED TO ALERT SURGEON OF PEDICLE LOCATION AND DEPTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571959 PEDIGUARD STIMULATOR, NERVE PDQ ORGENIX, LLC P1-AU414 15494H0072

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR