BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINEMAP® 3D 3.1 - SOFTWARE

    MDR report key: 13559643 · Received February 18, 2022

    Report

    Report Number
    3015967359-2022-00362
    Event Type
    Malfunction
    Date Received
    February 18, 2022
    Date of Event
    January 27, 2022
    Report Date
    April 27, 2022
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    HAW
    UDI-DI
    07613327359954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE: D9, H3, H6 . DEVICE EVALUATION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE DEVICE WAS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 0

    PER THE SURGEON, THERE WAS A POTENTIAL INACCURACY AT THE TIME OF DEVICE REGISTRATION DURING A LUMBAR FUSION PROCEDURE. THE SURGEON FELT UNCERTAIN ABOUT THE ACCURACY OF K-WIRES PLACEMENT AND TOOK ADDITIONAL FLURO SHOTS TO CONFIRM POSITION AND NOTED SUBOPTIMAL K-WIRE PLACEMENT WHICH WAS CORRECTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Description of Event or Problem · 0

    PER THE SURGEON, THERE WAS A POTENTIAL INACCURACY AT THE TIME OF DEVICE REGISTRATION DURING A LUMBAR FUSION PROCEDURE. THE SURGEON FELT UNCERTAIN ABOUT THE ACCURACY OF K-WIRES PLACEMENT AND TOOK ADDITIONAL FLURO SHOTS TO CONFIRM POSITION AND NOTED SUBOPTIMAL K-WIRE PLACEMENT WHICH WAS CORRECTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Description of Event or Problem · 0

    PER THE SURGEON, THERE WAS A POTENTIAL INACCURACY AT THE TIME OF DEVICE REGISTRATION DURING A LUMBAR FUSION PROCEDURE. THE SURGEON FELT UNCERTAIN ABOUT THE ACCURACY OF K-WIRES PLACEMENT AND TOOK ADDITIONAL FLURO SHOTS TO CONFIRM POSITION AND NOTED SUBOPTIMAL K-WIRE PLACEMENT WHICH WAS CORRECTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474206 SPINEMAP® 3D 3.1 - SOFTWARE NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 6002-680-000 VERSION: UNKNOWN 07613327359954

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown