An Analysis of a Decade of Lumbar Interbody Cage Failures in the United States: A MAUDE Database Study.

Abstract

A retrospective case series. This study aims to assess the rates of lumbar interbody cage failures based on their material and manufacturer. Perioperative lumbar interbody cage malfunctions are underreported events in the spine literature and may result in complications. Although the Food and Drug Administration ensures the safety of these devices under physiological conditions after implantation, these devices may experience nonphysiological conditions during implantation, which may be overlooked. The MAUDE database was examined for reports of lumbar cage device malfunctions from 2012 to 2021. Each report was categorized based on failure type and implant design. A market analysis was performed by dividing the total number of failures per year for each manufacturer by their approximate yearly revenue from spinal implants in the United States. Outlier analysis was performed to generate a threshold value above which failure rates were defined as greater than the normal index. Overall, 1875 lumbar cage malfunctions were identified. Of these, 1230 (65.6%) were cage breakages, 257 (13.7%) were instrument malfunctions, 177 (9.4%) were cage migrations, 143 (7.6%) were assembly failures, 70 (4.5%) were screw-related failures, and 21 (1.1%) were cage collapses. Of the breakages, 923 (74.9%) occurred during insertion or impaction and 97 entries detailed a medical complication or a retained foreign body. Of the migrations, 155 (88.6%) were identified postoperatively, of which 73 (47.1%) detailed complications and 52 (33.5%) required a revision procedure. Market analysis demonstrated that Medtronic, Zimmer Biomet, Stryker, Seaspine, and K2M exceeded the calculated threshold. Lumbar cages with polyether ether ketone core material failed more frequently by breakage, whereas titanium surface cages failed more frequently by migration. Failure rates varied depending on the manufacturer. Most cage breakages identified in the present study occurred intraoperatively during implantation. These findings call for a more detailed Food and Drug Administration evaluation of these intraoperative malfunctions before commercial approval. Level 4.