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

Model Number NVM5

Device Problems Crack (1135); Device Damaged Prior to Use (2284); Erratic Results (4059)

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

Event Date 09/26/2022

Event Type  malfunction  

Event Description

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 inconsistency's.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.

Manufacturer Narrative

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.

Manufacturer Narrative

The disposable dilators were not returned as they were disposed of at the user facility and no images or data reports provided confirming the event however, the involved nvm5 monitor was returned nuvasive after the case where service technicians identified and replaced three edge cards that were found cracked as well the power and two interconnecting cables were found damaged requiring replacement after which the unit passed all lpac required testing and found to be functioning as designed.The root cause of the reported inconsistencies in signal appear to be the result of accumulated physical damage and likely resulting from years of field usage, shipping and handling damage.No additional investigation required.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." ".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.".

Event Description

Changes and updates listed on section h10.

• 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: 15670638
• MDR Text Key: 307008651
• Report Number: 2031966-2022-00223
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00887517079855
• UDI-Public: 887517079855
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/14/2023

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: NVM5
• Device Lot Number: 2206033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 10/24/2022
• Supplement Dates FDA Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2014
• 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: 2029950 DILATOR
• Patient Sex: Prefer Not To Disclose