BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIGUARD

    MDR report key: 5382502 · Received January 21, 2016

    Report

    Report Number
    5382502
    Event Type
    Malfunction
    Date Received
    January 21, 2016
    Date of Event
    September 17, 2015
    Report Date
    November 24, 2015
    Manufacturer
    SPINEGUARD, SA
    Product Code
    GWF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SPINE SURGERY, THE SURGEON WENT TO USE A PEDIGARD PEDICLE FINDER AND FOUND THAT IT WAS DEFECTIVE. WE REMOVED IT FROM THE SURGICAL FIELD AND REPLACED IT WITH A NEW ONE. REPRESENTATIVE SAID IF STRUCK TOO HARD ON TOP IT WILL DISCONNECT THE MICROPHONE. THE DEVICE IS NOT BROKEN IF THE LIGHT STILL WORKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41719 PEDIGUARD STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF SPINEGUARD, SA CURVED XS

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR