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

Model Number 6140302

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

Patient Problem Laceration(s) (1946)

Event Date 06/20/2022

Event Type  Injury  

Event Description

It was reported on a clinical study that on (b)(6), 2022 a patient underwent a transforaminal interbody fusion.An incidental durotomy occurred during surgery and the patient was ordered to be on flat bedrest.No treatment was reported.

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 on 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.".

• Brand Name: NUVASIVE COHERE THORACOLUMBAR INTERBODY SYSTEM
• Type of Device: 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: 15809657
• MDR Text Key: 303799685
• Report Number: 2031966-2022-00258
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00887517017710
• UDI-Public: 887517017710
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6140302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female