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

Model Number	8181250P2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	01/11/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 9734660
• Report Number: 2031966-2020-00029
• Device Sequence Number: 3320765
• Product Code: MAX
• UDI-Device Identifier: 00887517982827
• UDI-Public: 887517982827
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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
• Operator of Device: Health Professional
• Device Model Number: 8181250P2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 73 YR