MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE UNIVERSAL INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 5010121

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/02/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent an initial extreme lateral interbody fusion.During the procedure, as the surgeon performed an incision of the anterior longitudinal ligament (all), an aortic injury occurred.Temporary hemostasis was achieved in order to place the interbody device and complete anterior fixation.Subsequently, a stent was placed and hemostasis was achieved.The patient's condition was determined to be stable with the total blood loss of approximately one (1) liter.The interbody fixation procedure was completed and the posterior fixation portion of the procedure was planned for completion at a later date.No additional patient consequences were reported.

Manufacturer Narrative

The reported event was unable to be confirmed due to limited information received from the customer.No device was returned to nuvasive for evaluation; further, operative notes and/or radiograph images were not provided for review of usage/technique.A definitive root cause was unable to be determined with the information provided.There are warnings in the device labeling that this type of event can occur: ".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." ".Intra-operative warnings: it is important that the surgeon exercise extreme caution when working in close proximity to vital organs, nerves, or vessels, and that the force applied to the instrumentation is not excessive, to prevent potential injury to the patient." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NUVASIVE UNIVERSAL INSTRUMENTS
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 13642677
• MDR Text Key: 286651072
• Report Number: 2031966-2022-00047
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00887517238474
• UDI-Public: 887517238474
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5010121
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: NUVASIVE COROENT XL INTERBODY
• Patient Outcome(s): Required Intervention
• Patient Sex: Male