MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE COROENT SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6080823P2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/01/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
No product has been returned for evaluation as it remained in-situ.No alleged product malfunction, no radiographic or photographic films have been provided at this time.Labeling review: ".Potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery.Rarely, some complications may be fatal." left in-situ.
Event or Problem Description
On (b)(6) 2018 a patient underwent a revision procedure of another manufacturers transforaminal lumbar interbody fusion.Nuvasive cages were placed at l5/s1 levels without any reported problems.During the extension of the previously placed posterior fixation, the patient's blood pressure decreased.Rod insertion, set screw tightening and placement of transverse connectors was performed and patient was closed.Cardiac massage and first aid treatment was performed.Patient was transferred to the intensive care unit and later expired.The cause of the patient's demise is unknown at this time.

• Brand Name: NUVASIVE COROENT SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7375934
• Report Number: 2031966-2018-00027
• Device Sequence Number: 2311835
• Product Code: MAX
• UDI-Device Identifier: 00887517679604
• UDI-Public: 00887517679604
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2018

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: Physician
• Device Model Number: 6080823P2
• Device Lot Number: ML0582
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/27/2018
• 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: Death