MAUDE Adverse Event Report: NUVASIVE, INC. COROENT INTERLOCK SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	6790225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Patient Problem/Medical Problem (2688)
Date of Event	08/08/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No allegation of product malfunction has been reported, no x-rays were provided to confirm the alleged event.Product remains in-situ.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: damage to blood vessels.".
Event or Problem Description
On (b)(6) 2014, patient underwent an anterior cervical discectomy and fusion procedure.Approximately six hours post-operatively patient was admitted to the hospital with swelling in the neck.Patient was taken back for an emergent procedure where a hematoma was found in the prevertebral space.Further exploration found arterial bleeding.As per reporter bleeding was cauterized primarily and bleeding stopped.

• Brand Name: COROENT INTERLOCK SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7601013
• Report Number: 2031966-2018-00103
• Device Sequence Number: 1799716
• Product Code: OVE
• UDI-Device Identifier: 00887517361608
• UDI-Public: 00887517361608
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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: 6790225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/14/2018
• 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: Hospitalization