BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUVASIVE PULSE SYSTEM

    MDR report key: 18636235 · Received February 2, 2024

    Report

    Report Number
    2031966-2024-00042
    Event Type
    Malfunction
    Date Received
    February 2, 2024
    Date of Event
    January 7, 2024
    Report Date
    February 2, 2024
    Manufacturer
    NUVASIVE, INC.
    Product Code
    OLO
    UDI-DI
    00887517990792
    PMA / PMN Number
    K210574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHOTOGRAPHS WERE PROVIDED AND NO DEVICE WAS RETURNED FOR EVALUATION. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED CONCLUSIVELY. LABELING REVIEW: "WARNINGS, CAUTIONS AND PRECAUTIONS... ...IF SYSTEM DATA ACQUISITION SEEMS INACCURATE OR IF THE SOFTWARE APPLICATION DOES NOT INITIATE OR MALFUNCTIONS DURING USE, AND RECOMMENDED STEPS TO RESTORE THE SYSTEM ARE NOT SUCCESSFUL, ABORT USE OF THE SYSTEM..." "...THE PULSE SYSTEM IS TO BE USED ONLY AS AN ADJUNCT TO MEDICAL JUDGMENT AND APPROPRIATE SURGICAL PRACTICES..." "INTRA-OPERATIVE WARNINGS... ...ASSESS NAVIGATIONAL ACCURACY REPEATEDLY THROUGHOUT A PROCEDURE WHEN USING A SURGICAL NAVIGATION SYSTEM. A) RECONFIRM ACCURACY BY POSITIONING THE NAVIGATED INSTRUMENT TIP ON AN IDENTIFIABLE ANATOMICAL LANDMARK AND COMPARING THE ACTUAL TIP LOCATION TO THAT DISPLAYED BY THE SYSTEM. B) IF THE STEREOTAXIC NAVIGATION SYSTEM DOES NOT APPEAR TO BE ACCURATE DESPITE TROUBLESHOOTING (E.G., RESETTING THE SYSTEM), DO NOT RELY ON THE NAVIGATION SYSTEM..." "...MOVEMENT OF THE PATIENT DURING THE COURSE OF 3D RADIOGRAPHIC IMAGE ACQUISITION MAY RESULT IN INACCURATE MEASUREMENTS. EFFORTS TO IMMOBILIZE THE PATIENT DURING DATA ACQUISITION SHOULD BE TAKEN TO RESTRICT PATIENT MOVEMENT. IF PATIENT MOVEMENT DURING DATA ACQUISITION IS OBSERVED OR SUSPECTED, RE-START THE DATA ACQUISITION PROCESS IN ORDER TO ENSURE ACCURATE IMAGE..." "...CAPTURING THE PATIENT REFERENCE ARRAYS FOR REGISTRATION CAN HAPPEN BEFORE YOU DRAPE OR AFTER YOU REMOVE THE DRAPE FROM THE PATIENT REFERENCE ARRAYS DURING 3D IMAGE ACQUISITION FOR NAVIGATION. MAKE SURE TO GENTLY DRAPE OVER THE PATIENT REFERENCE ARRAYS, ENSURING THE ARRAYS ARE NOT BUMPED OR MOVED IN THIS PROCESS. ANY MOVEMENT OF THE ARRAYS DURING THIS PROCESS COULD REQUIRE A RE-CAPTURE OF THE ARRAYS, OR EVEN RE-SCAN OF THE PATIENT IF THE REGISTRATION ACCURACY IS NOT ADEQUATE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DURING A PROCEDURE USING PULSE NAVIGATION A NAVIGATIONAL INACCURACY WAS SEEN WHEN INITIATING A TAP FOR THE RIGHT L4 PEDICLE SCREW. AFTER INITIATION OF THE TAP THE SURGEON REMARKED THAT THE ACCURACY APPEARED TO BE OFF. 2D X-RAY IMAGES WERE TAKEN AND CONFIRMED THE INITIAL TAP TRAJECTORY WAS MORE LATERAL THAN PLANNED. THE INITIAL TAP TRAJECTORY WAS NOT USED AND A SCREW WAS PLACED UNDER 2D X-RAY IN IN THE CORRECT POSITION. NAVIGATION WAS USED IN CONJUNCTION WITH 2D X-RAY FOR THE REMAINDER OF THE CASE AND SCREW PLACEMENT WAS FOUND TO CORRESPOND CORRECTLY ACROSS BOTH THE NAVIGATION AND X-RAY IMAGES, INDICATING ACCURATE NAVIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373395 NUVASIVE PULSE SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO NUVASIVE, INC. 1881500 NA 00887517990792

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose