MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE BASE INTERFIXATED TITANIUM SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number 6952810

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

Patient Problems Venipuncture (2129); Blood Loss (2597)

Event Date 06/10/2019

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation as no product malfunction was alleged.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." "potential risks identified with the use of this system, which may require additional surgery, include: neurological, vascular or visceral injury." device not returned.

Event Description

Patient underwent a spinal procedure on (b)(6) 2019.As per reporter during the procedure, the patient lost blood due to iliac vein puncture.No other patient information provided.

Manufacturer Narrative

Even though root cause cannot be confirmed, a review of the reported event suggests unintentional puncture of the left common iliac vein and subsequent blood loss was the result of incidental contact from an unidentified instrument.Labeling review: ".Warnings, cautions and precautions 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." ".Preoperative warnings care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".

Event Description

Additional or corrected information provided in sections: d4, d6, g3, g7, h2, h6.

• Brand Name: NUVASIVE BASE INTERFIXATED TITANIUM SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 9887224
• MDR Text Key: 189219565
• Report Number: 2031966-2020-00065
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• PMA/PMN Number: K170592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6952810
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR