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

Model Number 1025906

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

A radiograph was provided confirming the complaint.No device was returned as the device was left in-situ at the discretion of the assisting physician.The root cause of the failure is unknown but may be the result of removal technique.No further investigation to be completed.Label review "potential adverse events and complications - 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" "electrodes should be applied only to normal, intact, clean, healthy skin" "inspect all system components and packaging for damage before use.If components are visibly damaged, do not use the system" "caution should be exercised during skin preparation and electrode removal" "improperly placed or bent needles increase the risk of needle breaking off in the patient" "breakage of the device, which could make necessary removal difficult or sometimes impossible, with possible consequences of late infection and migration.Breakage could cause injury to the patient" devices remain in-situ.

Event Description

On (b)(6) 2021 a patient underwent a spinal procedure utilizing neuro monitoring where needles were placed for stimulation.The case was completed with no issue but upon removal of the needles one was observed to be missing.The missing needle was located in the patient via x-ray but the surgeon decided leave the device as is in-situ.The patient was informed post-op of the event.

• Brand Name: NUVASIVE NEXT GENERATION NVM5 SYSTEM
• Type of Device: 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: 11866466
• MDR Text Key: 252424440
• Report Number: 2031966-2021-00068
• Device Sequence Number: 1
• Product Code: PDQ
• UDI-Device Identifier: 00887517075338
• UDI-Public: 887517075338
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2021

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: 1025906
• Device Lot Number: J403230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1