BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURETRAK II UNIVERSAL TRACKER, MEDIUM CLAMP

    MDR report key: 4262268 · Received November 19, 2014

    Report

    Report Number
    1723170-2014-01241
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Date of Event
    October 31, 2014
    Report Date
    November 8, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    PMA / PMN Number
    K983670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: ON 13-OCT-2015, IT WAS NOTICED THAT A PREVIOUS MDR SUBMISSION CONTAINED INCORRECT INFORMATION WITH REGARDS TO THE COMMON DEVICE NAME, PRODUCT CODE AND/OR PMA/510(K). THIS MDR IS BEING SUBMITTED TO CORRECT THIS INFORMATION. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. DEVICE LOT NUMBER, OR SERIAL NUMBER, IS FOR TWO PARTS WITH THE SAME CATALOG NUMBER. PART #1 - LOT # 130429; PART #2 - LOT # 140528. DEVICE MANUFACTURING DATE IS FOR TWO PARTS WITH THE SAME CATALOG NUMBER. PART #1 - 04/29/2013; PART #2 - 05/28/2014. REPLACEMENT DEVICES SHIPPED TO SITE ON 11/3/2014 FOR ISSUE RESOLUTION.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT TWO CLAMP INSTRUMENTS EACH HAD A STRIPPED SCREW. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749578 SURETRAK II UNIVERSAL TRACKER, MEDIUM CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1