BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURETRAK® II UNIVERSAL TRACKER, LARGE CLAMP

    MDR report key: 3180413 · Received June 20, 2013

    Report

    Report Number
    1723170-2013-00460
    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

    CORRECTED REPORT:BRAND NAME CORRECTED TO READ SURETRAK II UNIVERSAL TRACKER, LARGE CLAMPCATALOG NUMBER CORRECTED TO READ 961-580.ALL OTHER INFORMATION ON INITIAL REPORT IS CORRECT AND REMAINS THE SAME.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RMA ISSUED. REPLACEMENT CLAMP SENT TO SITE (B)(4) 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 LARGE 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
    281104 SURETRAK® II UNIVERSAL TRACKER, LARGE CLAMP NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 120409

    Patients

    Seq Age Sex Outcome Treatment
    1