MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE GENERAL INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS

Model Number	6910220
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Tissue Damage (2104); Blood Loss (2597)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation as no product malfunction was alleged.No radiographs or images provided.Even though no root cause can be identified review of the reported event identified that the surgeon slipped during surgical procedure.A vascular repair was completed and the patient has reportedly recovered.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 known to occur include: early or late infection which may result in the need for additional surgeries; damage to blood vessels.".
Event or Problem Description
The patient underwent extreme lateral interbody fusion procedure at l1/3 on (b)(6) 2020.Reportedly, patients segmental artery was damaged while the physician was dissecting intervertebral disc with a cobb at l2/3 levels.Pressure hemostasis was conducted to stop bleeding and the patient was transferred to another hospital for vascular surgery treatment.A spinal procedure has been postponed and will be performed at a later date.

• Brand Name: NUVASIVE GENERAL INSTRUMENTS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 10396692
• Report Number: 2031966-2020-00160
• Device Sequence Number: 2705561
• Product Code: LXH
• UDI-Device Identifier: 00887517390196
• UDI-Public: 887517390196
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/12/2020

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: 6910220
• 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: 07/16/2020
• Initial Report FDA Received Date: 08/12/2020
• 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: Other; Required Intervention