MAUDE Adverse Event Report: NUVASIVE, INCORPORATED 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 Problems Pain (1994); Thrombosis (2100)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation as no product malfunction alleged.No radiographs or images were provided to confirm the alleged event.Even though root cause cannot be confirmed based on information provided the potential root cause may be related to patient condition and or surgical procedure.Labeling 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 include: damage to blood vessels." device still in-situ.

Event Description

On (b)(6) 2019 patient underwent spinal procedure at l2-s1 levels.As per reporter on (b)(6) 2019, the patient developed a superficial deep vein thrombosis in their right lower leg.The patient was experiencing leg pain.The patient was treated with medications and it was reported to have resolved on (b)(6) 2019.

• Brand Name: NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COROENT THORACOLUMBAR SYSTEM, COROENT
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR22
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd.; san diego CA 92121
• MDR Report Key: 10538982
• MDR Text Key: 207138074
• Report Number: 2031966-2020-00184
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K203201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• 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: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8221055P2; 8221055P2
• Patient Outcome(s): Other
• Patient Age: 71 YR