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

Model Number 2021000006

Device Problems Use of Device Problem (1670); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the local field office for evaluation.The system was tested but the reported power issue was unable to be replicated.The device was found to be functioning as intended.Based on the information obtained the root cause of the reported event is most likely improper or incomplete set-up and/or inadvertent operator error as no problem could be identified or recreated.No additional investigation can be completed at this time.Labelling 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." ".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." "method of use please refer to the nvm5 system product reference manual¿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.".

Event Description

During an l1 to l2 extreme lateral interbody fusion with posterior fixation in which an nvm5 system was planned to be used for intraoperative neuromonitoring the system would not power on and was unavailable for the case.As neuromonitoring guidance was unavailable, the surgeon elected to make the incision larger in order to gain visualization of the surgical area.

Event Description

Corrected information listed on h10.

Manufacturer Narrative

The device was returned to nuvasive japan where the complaint was confirmed.Examination of the returned system was completed under service number re01791 where the power button functionality was intermittent and the tactile feel was gone, further investigation determined the sw pcb had shifted inside the case misaligning the button with the interfacing opening in the front panel and disallowing complete motion/engagement of the power activation switch.The technician then re-positioned the sw pcb and confirmed functionality was restored.The root cause of the issue is considered physical/field damage, which can be the consequence of being dropped, shipping damage or excessive force applied to front panel.These devices are part of loaner systems that are subjected to the effects of handling with repeated assembly and disassembly in the field where wear and damage can occur.No additional investigation required.Related labeling 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." ".Precaution: 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." ".Method of use: please refer to the nvm5 system product reference manual (doc #9400247) 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." 9402521-en.

• Brand Name: NUVASIVE NEXT GENERATION NVM5 SYSTEM
• Type of Device: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 15338427
• MDR Text Key: 305621517
• Report Number: 2031966-2022-00170
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00887517069559
• UDI-Public: 887517069559
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

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
• Device Operator: Health Professional
• Device Model Number: 2021000006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NVM5 PATIENT MODULE 3 - JAPAN.PN 2021030006.
• Patient Sex: Male