Adverse events associated with the Barricaid annular closure device: An analysis of the FDA MAUDE Database.

Abstract

<h4>Background</h4>The Barricaid annular closure device (Intrinsic Therapeutics, Inc., Woburn, MA) functions to prevent reherniation in patients undergoing primary discectomies for L4-L5 or L5-S1 disc herniation with large annular defects. However, there are limited investigations assessing patient safety. This study analyzed clinical data on device malfunctions and adverse events to inform potential areas for improvements.<h4>Methods</h4>Adverse event reports related to the Barricaid device filed from January 1, 2020, to February 28, 2025, were retrieved from the U. S. Food and Drug Administration Manufacturer and User Facility Device Experience database. Event date, device type, device malfunction, and adverse event were recorded.<h4>Results</h4>101 adverse event reports were included in this study. The most common malfunction was device migration (30.7%), followed by unsuccessful implantations (26.7%), which were addressed either intraoperatively (22.8%) or in revision surgeries (4.0%). Reherniation was the most frequently reported device-related adverse event (36.6%), while other postoperative complications were anticipated following spine surgeries that involved implants. Revision surgeries were performed in 67 reports following discoveries of device malfunction and/or adverse events (66.3%). 46 reoperations involved partial or complete device removal (45.5%).<h4>Conclusion</h4>Device malfunctions and adverse events inform the importance of careful patient selection, meticulous device handling, and improved device design in enhancing patient safety and outcomes. Patients with frailty, comorbidities, or postimplant adverse events could be subject to increased morbidity and reoperations. Continued postmarketing improvements are needed to mitigate device malfunctions and adverse events.