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

Model Number 2021030

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 07/16/2020

Event Type  Injury  

Manufacturer Narrative

The complaint device, one (1) nvm5 control unit, was evaluated and the reported event was confirmed.The evaluation identified that a piece of loose plastic/glue had become trapped within the fan component of the control unit.The piece was removed and additional testing performed with no further issues identified.A review of previous servicing records for the unit was performed and no discrepancies were identified.The root cause of the display issue was attributed to the loose piece; however, the root cause of the loose piece was unable to be determined.Labeling review: "warning: the nvm5 system contains no user serviceable parts inside, and servicing (other than that explicitly defined elsewhere in this manual) must be performed by the manufacturer or its authorized agent.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: 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.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." "preventive maintenance: it is strongly recommended that the nvm5 system undergo factory inspections and maintenance procedures every 12 months." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Event Description

It was reported that the patient underwent an initial extreme lateral interbody fusion procedure with neuromonitoring.During the procedure, it was noted that the screen of the neuromonitoring unit went black while the unit continued to make noise.After several attempts, the screen turned on; however, due to the issues encountered, the surgeon opted to discontinue the lateral approach and convert the procedure to a posterior transforaminal lumbar interbody fusion.No further patient impact was reported.

• Brand Name: NUVASIVE NVM5 SYSTEM
• Type of Device: NEUROSURGICAL NERVE LOCATOR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA
• 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: 15442498
• MDR Text Key: 300121113
• Report Number: 2031966-2022-00182
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00887517168610
• UDI-Public: 887517168610
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K143641
• 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
• Report Date: 09/16/2022

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
• Device Operator: Health Professional
• Device Model Number: 2021030
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose