BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURETRAK® II UNIVERSAL TRACKER, SMALL CLAMP

    MDR report key: 3180433 · Received June 20, 2013

    Report

    Report Number
    1723170-2013-00459
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K983670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN.RMA ISSUED. REPLACEMENT CLAMP SENT TO SITE 05/23/2013. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT DEVICE FINDS THE HEAD OF THE SCREW IS ROUNDED OR STRIPPED OUT. PHYSICAL DAMAGE, DEFORMATION, DIRECTLY CAUSED THE EVENT.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE, PURCHASING, REPORTED A SMALL SURETRAK CLAMP TRACKER SCREW THAT WAS STRIPPED. THIS WAS IDENTIFIED IN STERILE PROCESSING. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279885 SURETRAK® II UNIVERSAL TRACKER, SMALL CLAMP NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 120317

    Patients

    Seq Age Sex Outcome Treatment
    1