Ten-year analysis of 17,639 thoracolumbar instrumentation failures using the manufacturer and user facility device experience (MAUDE) database
Year: 2026
Type: article
Abstract: Background: This study utilized the FDA-maintained Manufacturer and User Facility Device Experience (MAUDE) database, an extensive resource capturing medical device reports (MDRs) of adverse events, to perform a cross-sectional analysis of failure mechanisms reported by manufacturers. Methods: All thoracolumbar pedicle screw system failures reported in the MAUDE database between January 2014 and December 2023 were identified using FDA product codes. Failures were classified as intraoperative or postoperative and grouped into 9 and 5 clusters, respectively. Following de-identification, the 8 most frequently reported manufacturers were analyzed individually. Reports specifying failed components were categorized as screw, set screw, rod, instrument, system, other, or unknown. The "system failure" category lacked specificity regarding the failed component. Descriptive statistics summarized failure mechanisms. Results: A total of 17,639 MDRs related to thoracolumbar fixation failures were reported over the past decade, with 15,234 postoperative and 2,405 intraoperative events. The most frequent intraoperative issues were positioning problems (27.9%), device-device compatibility (26.4%), and difficulty in separation/removal (11.8%), while the most common postoperative failure mechanisms were breakage (45.2%), migration/detachment (42%), and deformation (10.1%). The distribution of failed components varied by the associated failure mechanism. Among 4,676 reported breakages, screws (20.8%), set screws (15.5%), and rods (11.8%) were most frequently involved. In the 4,871 migration/detachment events, set screws accounted for 31.6%, screws for 21%, and rods for 2.3%. Of 1,325 deformation events, the majority were linked to set screws (76.5%), with fewer attributed to system-level components (11.2%) and screws (6%). Conclusions: Failure profiles for pedicle screw systems vary significantly between manufacturers. The MAUDE database is a useful resource for the evaluation of reporting patterns associated with pedicle screw systems. However, limitations include reporting biases and the absence of total sales data, which prevents the calculation of true failure rates.
Authors: Gil Kimchi, Darcy Johnston, John Paul G. Kolcun, Jill Serbousek, Richard G. Fessler
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,950
OpenAlex ID: W7128036991