BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJ DRILL STOP 3.2MM

    MDR report key: 3822050 · Received May 20, 2014

    Report

    Report Number
    1723170-2014-00585
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 17, 2014
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K954276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LOT NUMBER, OR SERIAL NUMBER, NOT AVAILABLE. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. RMA ISSUED. REPLACEMENT ADJ DRILL STOP SHIPPED TO SITE. ON (B)(4) 2014 A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THE SUSPECT BIT STOP WAS LOOSER THAN A NEW INSTRUMENT WOULD BE. THE SITE REPORTED THAT THE DRILL STOP SEEMED TO ATTACH, HOWEVER, WHEN POWERED ON, IT VIBRATED AND WAS LOOSE. IT WAS ALSO REPORTED TO THE MEDTRONIC REPRESENTATIVE THAT THE PATIENT WAS FINE AND THIS EVENT HAD NO IMPACT ON THE PATIENT OUTCOME. THE SURGEON STATED THERE WAS NOT A BREACH OF THE ANTERIOR WALL OF THE VERTEBRAL BODY. SUSPECT PART NOT RECEIVED BY MANUFACTURER FOR ANALYSIS.

    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 RECEIVED A REPORT FROM A SITE ALLEGING THAT, WHILE IN A SPINE PROCEDURE, A BIT STOP FAILED AND THE SURGEON DRILLED FURTHER THAN DESIRED. NO FURTHER DETAILS WERE PROVIDED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299466 ADJ DRILL STOP 3.2MM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR