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

Model Number	6790114
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was returned as no product fault was alleged and no radiographs or other documentation could be provided confirming the alleged complaint.Review of the reported event identified a usage error where the surgeon was to close to the arterial branch and inadvertently damaged the artery.No device problem alleged or identified.No additional investigation will occur.Label 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: damage to blood vessels.Warnings, cautions and precautions - the subject device is intended for use only as indicated.The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.
Event or Problem Description
On (b)(6) 2022, a patient underwent an anterior cervical disc fusion procedure from c6-c7.While the surgeon was turning the angled driver the windows on the side of the driver allowed the inner shaft to capture a branch of the carotid artery as the internal shaft spun.As a consequence a branch of the carotid artery was torn.The surgeon alerted the vascular surgeon who repaired the artery.50ml of blood loss were recorded and no infusion was required and hemostasis was restored.The event resulted in a roughly 30 minute surgical delay and the surgery was completed with no further issue.The patient is recovering well post-op.

• Brand Name: NUVASIVE COROENT SMALL INTERLOCK SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 15674605
• Report Number: 2031966-2022-00224
• Device Sequence Number: 20434783
• Product Code: OVE
• UDI-Device Identifier: 00887517359933
• UDI-Public: 887517359933
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K192582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023
• 2 Devices were Involved in the Event: 1 2

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: 6790114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male