BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULATION?DISSECTION INSTRUMENTS

    MDR report key: 15670610 · Received October 25, 2022

    Report

    Report Number
    2031966-2022-00222
    Event Type
    Malfunction
    Date Received
    October 25, 2022
    Date of Event
    September 26, 2022
    Report Date
    March 8, 2023
    Manufacturer
    NUVASIVE, INCORPORATED
    Product Code
    ETN
    UDI-DI
    00887517170606
    PMA / PMN Number
    K112709
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER (B)(6) REPORTED UNDER FDA REPORT 2031966 - 2022 - 00222 IS THE SAME AS PATIENT AND EVENT PREVIOUSLY REPORTED AND INVESTIGATED UNDER PATIENT IDENTIFIER (B)(6) FDA REPORT 2031966 - 2022 - 00223 MAIN WITH I FOLLOW UP REPORT. THE SAME EVENT WAS ACCIDENTLY REPORTED TWICE THIS FILE CAN BE REDACTED AND REFERENCE FDA REPORT 2031966 - 2022 - 00223 FOR COMPLETED INVESTIGATION.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED AS THE DEVICE WAS DISPOSED OF AT THE USER FACILITY AND NO IMAGE OR DATA COULD BE PROVIDED CONFIRMING TO THE EVENT. NO ADVERSE PATIENT CONSEQUENCES OR INJURIES WERE REPORTED. NO ROOT CAUSE COULD BE PROVIDED AS RESULT OF THE LACK OF INFORMATION PROVIDED. HOWEVER REVIEW OF THE REPORTED EVENT SUGGEST INTERMITTENT CONTACT RELATED TO TECHNIQUE, CABLING CONNECTIONS AND/OR SKIN TO DEVICE CONDUCTIVITY. NO ADDITIONAL INVESTIGATION CAN BE COMPLETED. LABEL REVIEW "... WARNING: 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... " "...INSPECT ALL SYSTEM COMPONENTS AND PACKAGING FOR DAMAGE BEFORE USE. DO NOT USE STERILE COMPONENTS IF PACKAGING IS OPENED OR DAMAGED. IF COMPONENTS ARE VISIBLY DAMAGED, DO NOT USE THE SYSTEM..." "...THE NVM5 SYSTEM IS TO BE USED ONLY AS AN ADJUNCT TO MEDICAL JUDGMENT AND APPROPRIATE SURGICAL PRACTICES. DILATOR INSERTION AND ADVANCEMENT SHOULD BE CONDUCTED ONLY AFTER CAREFUL ANALYSIS OF RADIOGRAPHIC IMAGES OF THE OPERATIVE TARGET AREA. WHILE A POSITIVE EMG DETECTION BY THE NVM5 SYSTEM CAN BE ASSOCIATED WITH A HIGH LEVEL OF CERTAINTY THAT A NERVE IS IN CLOSE PROXIMITY TO THE DILATOR TIP, THE ABSENCE OF SUCH AN EMG DETECTION CANNOT BE CONSTRUED AS A CERTAIN INDICATION THAT NO NERVES ARE CLOSE TO THE DILATOR TIP. DO NOT ADVANCE DILATOR PROBES UNTIL ALL AVAILABLE DATA HAVE BEEN CONSIDERED. DO NOT ADVANCE THE DILATOR FASTER THAN THE RATE OF UPDATE OF DETECTION DATA..." "... PRE-OPERATIVE WARNINGS - THE METHODS OF USE OF INSTRUMENTS ARE TO BE DETERMINED BY THE USER¿S EXPERIENCE AND TRAINING IN SURGICAL PROCEDURES. THE INSTRUMENTS SHOULD BE CAREFULLY EXAMINED PRIOR TO USE FOR FUNCTIONALITY, EXCESSIVE WEAR, OR DAMAGE. A DAMAGED INSTRUMENT SHOULD NOT BE USED AS THIS MAY INCREASE THE RISK OF MALFUNCTION AND POTENTIAL PATIENT INJURY. "... INSPECT ALL COMPONENTS FOR DAMAGE BEFORE USE. CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT..." "... METHOD OF USE - PLEASE REFER TO THE NVM5 SYSTEM PRODUCT REFERENCE MANUAL (DOC #(B)(4)) FOR USE OF THE ENTIRE SYSTEM (SOFTWARE, CAMERA, AND ACCESSORIES). REFER TO THE INSTRUCTIONS FOR USE ACCOMPANYING OTHER NUVASIVE DEVICES FOR PROPER USE OF THESE DEVICES.

    Description of Event or Problem · 0

    THIS IS A DUPLICATE OF REPORT 2031966 - 2022 - 00223 AND FOLLOW UP REPORT 2031966 - 2022 - 00223 DETAILS ON SEC H10.

    Description of Event or Problem · 0

    ON (B)(6) 2022 A PATIENT UNDERWENT A LATERAL INTERBODY FUSION PROCEDURE ON UNKNOWN LEVELS OF THE SPINE. DURING THE PROCEDURE ONE OF THE NEURO MONITORING DILATORS WAS EXPERIENCING RESULT INCONSISTENCIES. THE ISSUE WAS FIXED WITH REDOCKING WHICH RESULTED IN A SMALL SURGICAL DELAY. THE SURGERY WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2556248 STIMULATION?DISSECTION INSTRUMENTS STIMULATION, NERVE ETN NUVASIVE, INCORPORATED 2029950 2035808 00887517170606

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose