BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUICK RELEASE BASE

    MDR report key: 1702151 · Received May 27, 2010

    Report

    Report Number
    1723170-2010-00028
    Event Type
    Other
    Date Received
    May 27, 2010
    Date of Event
    April 28, 2010
    Report Date
    April 28, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K030552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. ORTHO BASE WAS REPORTED AS AFTER TIGHTENING NOT BEING ABLE TO RELEASE. PRODUCT WAS RETURNED DAMAGED WITH A THREADED INSERT BROKEN FREE. NO FURTHER INVESTIGATION POSSIBLE.

    Description of Event or Problem · 1

    DURING AN ORTHOPEDIC SURGERY USING MEDTRONIC NAVIGATION'S TREON SYSTEM, SURGEON DRILLED A HOLE IN PATIENT AND INSERTED ONE PIN OF THE QUICK RELEASE BASE AND TIGHTENED IT. HE COULDN'T LOOSEN THE SCREW TO GET THE SECOND PIN IN. HE TWISTED THE BASE AROUND THE PIN TO GET IT OFF. HE THEN REMOVED THE BASE AND HAD TO BANG ON IT TO GET IT TO LOOSEN. THE BASE IS NOW BROKEN. THERE WAS NO IMPACT TO THE PATIENT, BUT THE DOCTOR HAD TO DRILL ADDITIONAL HOLES TO GET THE BASE ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK RELEASE BASE STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION NA 602091171

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention