BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAMP, THORACIC, RADIOLUCENT

    MDR report key: 2182367 · Received July 11, 2011

    Report

    Report Number
    1723170-2011-01213
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER NOT AVAILABLE AT TIME OF THIS REPORT. DEVICE MFR DATE IS DEPENDANT ON THE LOT NUMBER AND NOT AVAILABLE AT TIME OF THIS REPORT. RMA ISSUED FOR REPLACEMENT PART: LOT #110107, SHIPPED 06/27/2011.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THE SCREW OF THE THORACIC SPINE CLAMP WAS BEGINNING TO STRIP. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAMP, THORACIC, RADIOLUCENT STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1