MAUDE Adverse Event Report: NUVASIVE NUVASIVE COHERE THORACOLUMBAR INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 8181250P2

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

Patient Problem Pulmonary Embolism (1498)

Event Date 01/11/2020

Event Type  Injury  

Manufacturer Narrative

No product malfunction alleged nor radiographs or test results provided.Even though root cause cannot be confirmed, it is unknown if patient related factors and or surgical technique may have contributed to alleged event.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.".

Event Description

On an unknown date a patient underwent a posterior spinal procedure at l3-l5 levels without any reported issues.Post-operative, the patient was reported to have low oxygen saturation and shortness of breath.As per reporter, radiographs confirmed subacute pulmonary embolus.Patient was treated with medications.

• Brand Name: NUVASIVE COHERE THORACOLUMBAR INTERBODY SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: yobana sanchez ; 7475 lusk boulevard; san diego, CA 92121 ; 8589093383
• MDR Report Key: 9734660
• MDR Text Key: 183101494
• Report Number: 2031966-2020-00029
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00887517982827
• UDI-Public: 887517982827
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181860
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8181250P2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2020
• 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): Hospitalization
• Patient Age: 73 YR