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

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

Patient Problems Hernia (2240); Respiratory Failure (2484)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation as there was no allegation of product malfunction.The spine surgeon stated there was no defect with the materials that led to the diaphragmatic hernia.No films/xrays confirming the issue could be provided.".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 early or late infection; damage to blood vessels, spinal cord or peripheral nerves; dysphagia; dysphonia; dural tear or csf leak; esophageal injury; worsened neurologic status; vertebral artery injury; pulmonary emboli; loss of sensory and/or motor function; impotence; and permanent pain and/or deformity." device remains in-situ.

Event Description

On (b)(6) 2020 a patient underwent a extreme lateral interbody fusion corpectomy procedure.As per reporter, the spine surgeon resected the patient¿s th11 rib in approach to l1 and implanted the vertebral body replacement.Post-operatively, the patient was experiencing difficulty breathing, another surgeon examined the patient and found a diaphragmatic hernia.On (b)(6) 2020, the diaphragmatic hole was sutured.Patient is reported to be doing well.

Manufacturer Narrative

No product was returned for evaluation as there was no allegation of product malfunction.No films/xrays confirming the issue could be provided.The spine surgeon stated there was no defect or problem with nuvasive products that led to the diaphragmatic hernia.The root cause would be considered the result of inadvertent instrument or implant contact with the patients diaphragm and a unintended use error.".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 early or late infection; damage to blood vessels, spinal cord or peripheral nerves; dysphagia; dysphonia; dural tear or csf leak; esophageal injury; worsened neurologic status; vertebral artery injury; pulmonary emboli; loss of sensory and/or motor function; impotence; and permanent pain and/or deformity.".

Event Description

The patient underwent xlif procedure with x-core on (b)(6) 2020.The spine surgeon resected the patient¿s th11 rib in order to approach to l1 and implanted x-core.However post-operatively, the patient had difficulty breathing, so another surgeon examined the patient and found a diaphragmatic hernia.As a result of the examination, it found that the patient¿s stomach had entered the pleural side through the diaphragmatic hole and had compressed the patient¿s lungs.On (b)(6) 2020, the surgeon sutured the diaphragmatic hole.It was reported that the patient is doing well.The spine surgeon considers that there was no defect with our products.No films/xrays confirming the issue could be provided.The patient is recovering well from the diaphragmatic hernia.

• Brand Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Type of Device: NUVASIVE X-CORE(R) EXPANDABLE VBR SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 10787065
• MDR Text Key: 214629138
• Report Number: 2031966-2020-00200
• Device Sequence Number: 1
• Product Code: MPQ
• Combination Product (y/n): N
• PMA/PMN Number: K142205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/29/2020

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention