MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE NVM5 SYSTEM; NEUROSURGICAL NERVE LOCATOR

Model Number	2021001
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
While attempting to start stimulation using an nvm5 device for neuromonitoring during an extreme lateral interbody fusion (xlif) procedure, the nvm5 experienced an error which stopped stimulation functionality.Several troubleshooting attempts were made; however, the issue could not be resolved.As a result, neuromonitoring could not be performed and the surgeon had to change the surgical plan, closing the xlif surgical site and performing a transforaminal lumbar interbody fusion procedure instead.There was no further patient impact reported.
Additional Manufacturer Narrative
The unit was returned for evaluation.The unit was found to exhibit a windows error that impacted function and required reimaging to resolve.No other issues were found during inspection and testing.The unit was reimaged and passed all final inspection and testing criteria.Labeling review: ".As with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries." ".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." ".While the nvm5 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.".

• Brand Name: NUVASIVE NVM5 SYSTEM
• Common Device Name: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 13674298
• Report Number: 2031966-2022-00050
• Device Sequence Number: 12131140
• Product Code: PDQ
• UDI-Device Identifier: 00887517168610
• UDI-Public: 887517168610
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K162313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2021001
• Was Device Available for Evaluation?: Yes
• 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: 02/08/2022
• Initial Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2011
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose