BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAP [4.5 MM]

    MDR report key: 1961134 · Received January 12, 2011

    Report

    Report Number
    1723170-2011-00035
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE LOT NUMBER AND MANUFACTURE DATE ARE PROVIDED VERIFIED THAT THE TAP SHOWS EXCESSIVE WEAR ON 8 OF THE TRAILING EDGES OF THE TAP THAT FORMS THE THREAD FORM. ALTHOUGH THE TAP SHOWS WEAR, IT IS INCONCLUSIVE THAT IT CAUSED A CRACK. PATIENT AGE, GENDER, SURGEON PROCEDURE COULD ALL BE CONTRIBUTING FACTORS, OR IF SURGEON DRILLED TOO SMALL OF HOLE, THIS COULD ALSO BE A CONTRIBUTING FACTOR. UNDER MAGNIFICATION, TAP SHOWED EVIDENCE OF WEAR PATTERN DEVELOPING ON 8 OF THE TAPS ON THE TRAILING EDGE OF EACH TAP FORM (USING THE TIP AS FRAME OF REFERENCE). IT IS UNKNOWN IF DEFECT PRESENT AT MANUFACTURE, AS IT COULD HAVE WORSENED OVER USE.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER AS OF THIS REPORT, SO LOT NUMBER CANNOT BE DETERMINED. DEVICE MANUFACTURE DATE NOT AVAILABLE AT THE TIME OF THIS REPORT. DEVICE NOT YET RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE 4.5 LEGACY TAP USED DURING A SURGERY WAS WORN OUT, CAUSING A MINOR CRACK ON THE PT'S PEDICLE (L3 LEFT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAP [4.5 MM] STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA 100525

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention