BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL DRILL GUIDE

    MDR report key: 453084 · Received April 9, 2003

    Report

    Report Number
    1723170-2003-00002
    Event Type
    Malfunction
    Date Received
    April 9, 2003
    Date of Event
    December 11, 2002
    Report Date
    March 10, 2003
    Manufacturer
    MEDTRONIC SURGICAL NAVIGATION
    Product Code
    LXI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TIP OF A UNIVERSAL DRILL GUIDE WAS FOUND IN THE PT'S NECK AFTER 3 MONTHS VIA NORMAL POST-OP X-RAY. THE CAUSE OF THE EVENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL DRILL GUIDE UNIVERSAL DRILL GUIDE LXI MEDTRONIC SURGICAL NAVIGATION 960-521 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention