BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 2193526 · Received July 21, 2011

    Report

    Report Number
    1723170-2011-01256
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFO PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. LOT NUMBER UNK AT TIME OF THIS REPORT. DEVICE MFR DATE IS DEPENDENT ON THE LOT NUMBER. QUOTE FOR REPLACEMENT PART PROVIDED TO THE SITE.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THE SITE'S OPEN SPINE CLAMP IS STRIPPED AND THE SITE WANTS TO REPLACE IT. THE SITE REPORTED THEY DISCOVERED THIS ISSUE WITHOUT A PT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPEN SPINE CLAMP, TITANIUM STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE