BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINEMAP® 3D 3.0 - SOFTWARE

    MDR report key: 6137832 · Received December 1, 2016

    Report

    Report Number
    0001811755-2016-02801
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    November 7, 2016
    Report Date
    January 30, 2018
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    OLO
    PMA / PMN Number
    K141941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT DEVICE EVALUATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINE PROCEDURE CONDUCTED AT THE USER FACILITY, A 2-3 MM LATERAL SHIFT IN ACCURACY WAS EXPERIENCED. WHILE THE CASE WAS COMPLETED SUCCESSFULLY WITH THE USE OF NAVIGATION, THE SURGEON ALSO CHOSE TO CONFIRM HIS SCREW PLACEMENT WITH X-RAY. THE REPORTED ADVISED THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR PROCEDURAL DELAYS ASSOCIATED WITH THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINE PROCEDURE CONDUCTED AT THE USER FACILITY, A 2-3 MM LATERAL SHIFT IN ACCURACY WAS EXPERIENCED. WHILE THE CASE WAS COMPLETED SUCCESSFULLY WITH THE USE OF NAVIGATION, THE SURGEON ALSO CHOSE TO CONFIRM HIS SCREW PLACEMENT WITH X-RAY. THE REPORTED ADVISED THAT THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR PROCEDURAL DELAYS ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789372 SPINEMAP® 3D 3.0 - SOFTWARE ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO STRYKER INSTRUMENTS-KALAMAZOO VERSION: 3.0-45

    Patients

    Seq Age Sex Outcome Treatment
    1