BEUDAMED
    FDA Adverse Event Other Summary report: N

    LONG RIGHT TACTILE PROBE

    MDR report key: 1579901 · Received January 12, 2010

    Report

    Report Number
    1723170-2010-00001
    Event Type
    Other
    Date Received
    January 12, 2010
    Date of Event
    December 16, 2009
    Report Date
    December 16, 2009
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K954276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF PRODUCT IS ANTICIPATED. PRODUCT HAS BEEN RECEIVED BY MEDTRONIC AND EXPECTED TO BE ANALYZED. RESULTS FROM ALL EVALUATIONS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE MEDTRONIC SUPPORT SPECIALIST WAS PRESENT DURING A CASE. THE SITE WAS USING THE RIGHT LONG TACTILE, 962011S FOR THE FIRST TIME AND THE TIP BROKE OFF IN THE VERTEBRA. THE DOCTOR WAS UNABLE TO GET THE TIP OUT DUE TO THE DEPTH. THE DOCTOR DECIDED TO LEAVE THE PROBE FRAGMENT IN THE PATIENT BECAUSE IT WAS TOO DEEPLY IMBEDDED IN THE PATIENT'S BONE TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG RIGHT TACTILE PROBE STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION 962011S 090106

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other