BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTECHGPS® TOTAL SHOULDER APPLICATION

    MDR report key: 21362442 · Received February 12, 2025

    Report

    Report Number
    3008027912-2025-00001
    Event Type
    Injury
    Date Received
    February 12, 2025
    Date of Event
    January 8, 2025
    Report Date
    February 12, 2025
    Manufacturer
    BLUE ORTHO
    Product Code
    OLO
    PMA / PMN Number
    K213546
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MAIN ROOT CAUSE OF PROBLEM IS A MISUSE. THE SURGEON PERFORMED BAD ACQUISITIONS AND DID NOT CONSIDER THE INFORMATION DISPLAYED BY THE SOFTWARE PAGE (AND USER MANUAL GUIDELINES) TO CHECK THE ACQUISITIONS ACCURACY. THEREFORE, INCONSISTENT NAVIGATED VALUES WERE DISPLAYED BY THE SOFTWARE APPLICATION INDUCING GLENOID FRACTURE.

    Description of Event or Problem · 0

    A FRACTURE OF GLENOID HAPPENED WHILE DRILLING CENTER CAGE IN THE GLENOID WITH THE GPS SYSTEM. TO ACHIEVE PROPER FIXATION OF THE BASEPLATE, THE SURGEON HAD TO DRILL A NEW HOLE FOR CENTER CAGE (NOT USING THE GPS SYSTEM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645812 EXACTECHGPS® TOTAL SHOULDER APPLICATION SURGICAL NAVIGATION SYSTEM OLO BLUE ORTHO L00040 V2.2 N/A SINCE SOFTWARE APPLICATION

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Other