MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COROENT THORACOLUMBAR SYSTEM, COROENT; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR22

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

Patient Problem Hernia (2240)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

No product malfunction alleged.No radiographs or images provided so the complaint was not confirmed.No root cause could be determined however, review of the reported event describes a hernia was identified that suggested possible inadvertent instrument contact took place.No additional investigation can be completed.Labeling review: ".Potential adverse events and complications as with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; pulmonary emboli; loss of sensory and/or motor function; pleural effusions, hemothorax, chylothorax, pneumothorax, subcutaneous emphysema, need for chest tube insertion, intercostal neuralgia, rib fracture, diaphragm injury; atelectasis; impotence; permanent pain and/or deformity.Rarely, some complications may be fatal." ".Warnings, cautions and precautions: the subject device is intended for use only as indicated.The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." ".Pre-operative warnings: 5.Care should be used during surgical procedures to prevent damage to the devices and injury to the patient.".

Event Description

A patient underwent a xlif surgery.On (b)(6) 2018, the patient developed an inguinal hernia postoperatively.

Manufacturer Narrative

The mdr was submitted in error.A reassessment of the investigation was conducted.There are no reports of a nuvasive device causing or contributing to this reported event.

• Brand Name: NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COROENT THORACOLUMBAR SYSTEM, COROENT
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR22
• Manufacturer (Section D): NUVASIVE INC.; 7574 lusk blvd; san diego CA 92121
• MDR Report Key: 11220831
• MDR Text Key: 228419152
• Report Number: 2031966-2021-00019
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• PMA/PMN Number: K203201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2021
• 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
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other