BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG PERCUTANEOUS CLAMP

    MDR report key: 1935864 · Received December 3, 2010

    Report

    Report Number
    1723170-2010-00144
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001153
    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. MANUFACTURE DATE UNK AT THE TIME OF THIS REPORT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT A SPINE CLAMP WAS NOT RIGIDLY FIXED. THERE WAS NO PT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG PERCUTANEOUS CLAMP STEREOTAXIC SYSTEM (HAW) HAW MEDTRONIC NAVIGATION, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE