BEUDAMED
    FDA Adverse Event Other Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 1694425 · Received May 12, 2010

    Report

    Report Number
    1723170-2010-00017
    Event Type
    Other
    Date Received
    May 12, 2010
    Date of Event
    April 12, 2010
    Report Date
    April 12, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    IZL
    PMA / PMN Number
    K050996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT AVAILABLE FOR EITHER PT BUT HAS BEEN REQUESTED. DEVICE IS CURRENTLY BEING RETURNED TO MEDTRONIC NAVIGATION (B)(4). EVAL WILL BE CONDUCTED ON THE PRODUCT UPON RECEIVING DEVICE.

    Description of Event or Problem · 1

    DURING SPINE CASED IN (B)(6), THE SURGEON DISCOVERED MIS-POSITIONED SCREW PLACEMENT. THIS OCCURRED IN TWO SEPARATE CASES AFFECTING TWO DIFFERENT PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O-ARM 1000 IMAGING SYSTEM MOBILE X-RAY SYSTEM (IZL) IZL MEDTRONIC NAVIGATION BI-700-00021 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention