MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE PULSE SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	1881500
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Nervous System Injury (2689)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was returned to nuvasive for evaluation; however, the system logs were exported and sent to nuvasive software development engineering for evaluation.A review of the system logs did not indicate any system issues that could have contributed to the reported event.Additionally, it was reported that the posterior portion of the procedure was conducted without the use of neuromonitoring and it is currently unknown whether surgical steps performed during the posterior portion may have contributed to the post-operative deficit the patient experienced.Based on the information obtained, the root cause of the reported event cannot be determined conclusively.Labelling review: "potential adverse events and complications.As with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications include: tissue or nerve damage.Sensory or motor deficits." "warnings, cautions and precautions.¿while the pulse system is designed to assist in the electromyographic location of spinal nerves in proximity to the surgical site, it is not intended to take the place of thorough knowledge of spinal anatomy and appropriate surgical technique, nor should the information provided by the system be construed as definitive indicators of nerve location.Such factors as the distance from the nerve, the position and placement of electrodes, individual muscle and/or nerve responses, the proximity and strength of sources of electrical interference, and other patient and environmental factors, may influence the operation.If, in the judgment of the clinician, this resistance is sufficient to preclude proper placement of instruments, the procedure should be suspended." ".If the patient moves, or is moved, during the course of surgery, electrode positions may be disturbed.In such instances, electrode positions should be re-examined to confirm proper location, adequacy of contact, and security of connections.Run electrode test to affirm adequacy of emg electrode contact.".
Event or Problem Description
It was reported that a patient underwent an l3 to l5 extreme lateral interbody fusion with l5 to s1 transforaminal lumbar interbody fusion and posterior spinal fusion case using the pulse system for neuromonitoring.During patient repositioning to prone for the posterior fusion portion of the procedure, the connection to neuromonitoring was lost.Troubleshooting was able to re-establish the connection; however, the surgeon did not want to continue monitoring; thus, no neuromonitoring was used during the posterior portion of the case.Post-operative evaluation identified that the patient had sustained a left leg deficit.Per the surgeon, it is unknown whether the system did not accurately represent nerve proximity or the patient did not respond to stimulation as typically expected.

• Brand Name: NUVASIVE PULSE SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 18016898
• Report Number: 2031966-2023-00240
• Device Sequence Number: 20493801
• Product Code: OLO
• UDI-Device Identifier: 00887517990792
• UDI-Public: 887517990792
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K210574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1881500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Prefer Not To Disclose