BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 1932145 · Received December 14, 2010

    Report

    Report Number
    1723170-2010-00177
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    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 INFORMATION PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A MEDTRONIC REPRESENTATIVE REPLACED THE DEVICE AT THE SITE AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE TOP OF THE SCREW THAT IS USED TO OPEN AND CLOSE THE SPINE CLAMP WAS STRIPPED FROM OVERUSE OF THE DRIVER. THERE WAS NO PT PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE