MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE X-CORE EXPANDABLE VBR SYSTEM, NUVASIVE X-CORE MINI CERVICAL EXPANDABLE; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 04/01/2015

Event Type  Injury  

Manufacturer Narrative

No product was returned as no product fault was alleged.No films could be provided confirming the dural tear.The issue was discovered via a literature review (evaluation of the effectiveness of expandable cages for reconstruction of the anterior column of the spine) and no additional information could be obtained.The root cause of the issue is a unintended use error.No additional investigation required.".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 include.Dural tear." device remains in-situ.

Event Description

On (b)(6) 2015 a male patient underwent a spinal procedure using a thoracotomic lateral as well as posterior approach on the t7-t8 levels.During the procedure they attempted to remove a tumor that was discovered on the dura and a small laceration of the dura took place.It was reported to have occurred in error however the patient experienced no negative symptoms or health impacts as a consequence of the tear.It is unknown what the severity of the tear was or what was done to address it.

• Brand Name: NUVASIVE X-CORE EXPANDABLE VBR SYSTEM, NUVASIVE X-CORE MINI CERVICAL EXPANDABLE
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 12366482
• MDR Text Key: 268101123
• Report Number: 2031966-2021-00109
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K193506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other