Related Experiment Video
Updated: Mar 12, 2026
Minimally Invasive Treatment for Thoracolumbar Burst Fracture Using Sagittal Alignment Screws and A Trauma Reduction Device
Published on: November 8, 2024
Ten-year analysis of 17,639 thoracolumbar instrumentation failures using the manufacturer and user facility device
Gil Kimchi1,2, Darcy Johnston3, John Paul G Kolcun1
1Department of Neurosurgery, Rush University Medical Center, 1725 W. Harrison St., Chicago, IL 60612, United States.
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.
Insights
This study analyzed 17,639 thoracolumbar pedicle screw failures reported to the FDA MAUDE database. Breakage, migration, and deformation were common postoperative failures, with screws and set screws frequently involved.
Area of Science:
- Spinal Surgery
- Medical Device Analysis
- Biomedical Engineering
Background:
- The Manufacturer and User Facility Device Experience (MAUDE) database collects medical device reports (MDRs) on adverse events.
- Understanding device failure mechanisms is crucial for improving patient safety and surgical outcomes.
Purpose of the Study:
- To perform a cross-sectional analysis of failure mechanisms for thoracolumbar pedicle screw systems.
- To identify common failure modes and involved components using FDA MAUDE data.
Main Methods:
- A decade of MAUDE data (2014-2023) on thoracolumbar pedicle screw failures was analyzed.
- Failures were classified as intraoperative or postoperative and by component (screw, set screw, rod, etc.).
- Descriptive statistics were used to summarize failure mechanisms and component involvement.
Main Results:
- Over 17,000 MDRs indicated thoracolumbar fixation failures, predominantly postoperative (15,234).
- Common postoperative failures included breakage (45.2%), migration/detachment (42%), and deformation (10.1%).
- Screws, set screws, and rods were frequently implicated in breakage and migration events, while set screws dominated deformation failures.
Conclusions:
- Failure profiles of pedicle screw systems differ significantly across manufacturers.
- The MAUDE database provides valuable insights into device failure reporting patterns.
- Limitations include potential reporting biases and lack of sales data, precluding true failure rate calculation.
