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

Model Number	6200450P2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pulmonary Embolism (1498); Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No allegation of product malfunction has been reported.No information on patients' pre-existing conditions has been provided nor radiographs, images and/or surgical notes provided.Based on the information provided at this time no root cause could be determined.Though pulmonary embolism is a known complication for post-operative spinal patients it is unclear if the pulmonary embolism was related to nuvasive products.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: pulmonary emboli.".
Event or Problem Description
On march 2, 2019, the following event was reported at a physician conference on a coroent xl-h.Case 2: on an unknown date a procedure using coroent xl-h was performed.Post procedure, a symptomatic pulmonary embolism and back side deep infection occurred.

• Brand Name: NUVASIVE COROENT SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 8465483
• Report Number: 2031966-2019-00176
• Device Sequence Number: 11049662
• Product Code: ODP
• UDI-Device Identifier: 00887517295415
• UDI-Public: 00887517295415
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2019

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: 6200450P2
• 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: 03/04/2019
• Initial Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1