BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS REFERENCE CROSS PIN FRAME

    MDR report key: 4243539 · Received November 11, 2014

    Report

    Report Number
    1723170-2014-01211
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 17, 2014
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    PMA / PMN Number
    K131425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THE REFERENCE FRAME WAS NOT BROKEN. IT APPEARED SOMEONE REMOVED THE RUBBER BUMPER FROM THE TOP OF THE PERCUTANEOUS PIN IN ERROR. THE FRAME HAS BEEN USED 3 TIMES SINCE THIS REPORTED EVENT WITHOUT ISSUE - IT IS REPORTED TO BE WORKING FINE. NO FURTHER ACTION REQUIRED. SITE CANCELLED REPLACEMENT PERCUTANEOUS REFERENCE CROSS PIN FRAME, AND DECLINED TO RETURN THE SUSPECT DEVICE TO MANUFACTURER FOR ANALYSIS. PART NOT RETURNED TO MANUFACTURER.

    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.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, A PERCUTANEOUS REFERENCE CROSS PIN FRAME WAS DAMAGED AND THE SITE REQUESTED REPLACEMENT. THE INTERNAL SPRING THAT MATES THE PERCUTANEOUS PIN TO THE REFERENCE FRAME WAS MISSING. THE SITE USED TAPE TO SECURE THESE INSTRUMENTS TOGETHER WITHOUT ISSUE. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THE SURGEON OPTED TO CONTINUE, AND COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726846 PERCUTANEOUS REFERENCE CROSS PIN FRAME ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 120217

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR