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

Model Number	6980845
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Death
Additional Manufacturer Narrative
Product has not returned for evaluation, no device malfunctions have been reported.The cause of the event is not clear.".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." ".Preoperative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." surgical facility retained the device.
Event or Problem Description
Received information stating patient was undergoing a lateral discectomy/fusion procedure.While performing discectomy at the l4-l5 disc space, the iliac vein was lacerated.The patient's hemodynamic status became unstable, was unable to be resuscitated and subsequently expired.There is no allegation of instrument malfunction.

• Brand Name: COROENT XL
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTERGRATED BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6574335
• Report Number: 2031966-2017-00051
• Device Sequence Number: 612995
• Product Code: MAX
• UDI-Device Identifier: 00887517402998
• UDI-Public: 00887517402998
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K141665
• 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): 05/17/2017

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: 6980845
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/17/2017
• 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