BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP DRIVER

    MDR report key: 2193492 · Received July 21, 2011

    Report

    Report Number
    1723170-2011-01253
    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 PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. LOT NUMBERS UNKNOWN AT TIME OF THIS REPORT. DEVICE MANUFACTURE DATES ARE DEPENDANT ON THE LOT NUMBERS. QUOTE FOR TWO REPLACEMENT PARTS PROVIDED TO THE SITE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT TWO OF THE SITE'S SPINE CLAMP DRIVERS ARE STRIPPED AND THE SITE WANTS TO REPLACE THEM. THE SITE REPORTED THEY DISCOVERED THIS ISSUE WITHOUT A PATIENT PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE