BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE PROBE

    MDR report key: 1960951 · Received January 10, 2011

    Report

    Report Number
    MW5018955
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 23, 2010
    Report Date
    January 10, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING A LUMBAR FUSION IN THE OPERATING ROOM WHEN THE TIP OF THE PEDICLE PROBE BROKE OFF. THE SURGEON DETERMINED THAT THE PIECE WAS NOT RETRIEVABLE AFTER VIEWING VIA FLUOROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDICLE PROBE PEDICLE PROBE KWP MEDTRONIC UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR