MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COHERE THORACOLUMBAR INTERBODY; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6120254P2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no product returned for evaluation, as no product malfunction was alleged or identified.Review of the provided information identified a surgical error took place causing an incidental durotomy unrelated to nuvasive product functionality.No additional investigation needed.Labeling review: "warnings, cautions, and precautions: dural leak in cases of excessive load application or impingement of close vessels, nerves, and or organs by slippage or misplacement of the instrument." "potential adverse events and complications: infrequent operative and postoperative complications that may result in the need for additional surgeries.Potential risks identified with the use of this system, which may require additional surgery include neurological, vascular or visceral injury, dural leak." "pre-operative warnings: care should be used during surgical procedures to prevent damage to the devices and injury to the patient." "intra-operative warnings: the physician should take precautions against putting undue stress of the spinal area with instruments.Any surgical technique should be carefully followed.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." device still in-situ.
Event or Problem Description
This complaint was created from a lumbar interbody clinical review that a patient underwent a transforaminal lumbar interbody fusion at l5/s1 on (b)(6) 2022.During the procedure it was noted that there was an incidental durotomy intraoperatively due to the degree of stenosis.Durotomy occurred posteriorly at l5/s1 and was repaired with duragen and duraseal.

• Brand Name: NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COHERE THORACOLUMBAR INTERBODY
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 13956786
• Report Number: 2031966-2022-00068
• Device Sequence Number: 12025347
• Product Code: MAX
• UDI-Device Identifier: 00887517020789
• UDI-Public: 887517020789
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K203714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2022

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: 6120254P2
• 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: 03/09/2022
• Initial Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female