An Analysis of the Complication Reports of Expandable Lumbar Interbody Cages in the Food and Drug Administration Manufacturer and User Facility Device Experience Database.

Abstract

Background: Expandable lumbar interbody cages (ELICs) are commonly used for interbody fusion and provide lordotic correction by lengthening the anterior column of the vertebral spine. We sought to identify unique failure mechanisms and significant differences in the types of complications associated with ELICs as reported to the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) Database.

Materials and methods: The MAUDE Database was analyzed for complication reports submitted for ELIC systems between January 2013 and July 2023. Reports were categorized by manufacturer, brand name, type of expandable cage, type of complication, year of complication, and reporter identity. Reports that were duplicated or had insufficient information were excluded from analysis. The top 5 manufacturers with the most implant-related complications were independently analyzed and compared.

Results: A total of 821 reports were analyzed. The top 5 complications reported across all manufacturers were cage breakage during insertion (25.7%), postoperative migration without collapse (16.0%), postoperative collapse (15.6%), inserter breakage (11.1%), and tubing problems (3.0%). A significant difference was detected in complication type between manufacturers (χ²=557, P<.001). The largest number of reports (120, 14.6%) was in 2016.

Conclusion: With FDA approval of novel ELIC systems and the adoption of newer surgical techniques, understanding the range of potential complications is paramount in ensuring patient safety. This study of the MAUDE Database provides a comprehensive summary of adverse reported events associated with ELICs during the past decade. [Orthopedics. 202x;4x(x):xx-xx.].