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

Model Number	6900935
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been retuned for evaluation as there was no device malfunction alleged or identified.No images were provided therefore event was unable to be confirmed.Even though root cause cannot be confirmed, based on information provided potential use error may have contributed to event.The artery was repaired during the procedure and the patient was reported as doing well.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; spinal cord or peripheral nerves, pulmonary emboli; loss of sensory and/or motor function; impotence; permanent pain and/or deformity.Rarely, some complications may be fatal." no device malfunction alleged.
Event or Problem Description
On (b)(4) 2019 a patient underwent a corpectomy utilizing a ronguer at l1 level.As per reporter the patient's somatic artery was damaged intra-operative.The physician managed to stop bleeding.

• 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: 10139145
• Report Number: 2031966-2020-00125
• Device Sequence Number: 3361377
• Product Code: LXH
• UDI-Device Identifier: 00887517387462
• UDI-Public: 887517387462
• 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): 06/10/2020

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: 6900935
• Device Lot Number: FD4283909
• 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: 10/02/2019
• Initial Report FDA Received Date: 06/10/2020
• 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
• Patient Age: 84 YR