Mechanical Failure of Anterior Cervical Plate Systems: A Manufacturer and User Facility Device Experience (MAUDE) Database Analysis
Abstract
Abstract Purpose. Anterior cervical discectomy and fusion (ACDF) is among the most common spine procedures, and anterior plate fixation is central to many constructs. We characterized the mechanical failure modes reported for these devices and examined how each mode was distributed across injury and malfunction event coding. Methods. We performed a cross-sectional analysis of the FDA Manufacturer and User Facility Device Experience (MAUDE) database for anterior cervical plate systems (2010–2025). Reports were deduplicated, confirmed by structured narrative review, and classified into prespecified failure themes. Annual report volume was modeled by negative binomial regression with Mann-Kendall confirmation. Failure theme and event type were compared by chi-square test; injury-versus-malfunction odds ratios (ORs) came from Fisher’s exact tests. Results. Of the 5,077 reports, 4,775 (94.1%) were assigned a primary failure theme, and 302 (5.9%) remained unclassified. Among classified reports, the most common primary failure themes were screw backout or loosening (n = 1,513; 31.7%), locking-mechanism failure (n = 1,052; 22.0%), and screw breakage (n = 920; 19.3%). Injury coding was most associated with subsidence/nonunion (OR 7.74), revision or removal (OR 3.70), migration or displacement (OR 2.72), and dysphagia/esophageal complications (OR 2.37). Death-coded reports were uncommon and reflected perioperative complications rather than mechanical failure. Conclusion. Subsidence or…
How strong is the evidence?
Evidence Hub reads this as a cross-sectional. Its evidence level is 4 of 5 (Low · observational). Observational designs can show an association but not prove cause. Reported size: 1,513 participants or records.
Read the paper
Related studies
- Regulation of nucleolus assembly by non-coding RNA polymerase II transcripts
- For a Healthy Histone Code, a Little SUMO in the Tail Keeps the Acetyl Away
- Discovering a binary CTCF code with a little help from BORIS
- Article Commentary: Stabilizing the Code–-Methods to Preserve RNA Prove Their Worth
- Foreword to the Special Issue for the RINTC (The Implicit Seismic Risk of Code-Conforming Structures) Project
- Commentary: Promoting Health and Well-being in Pediatric Primary Care Settings: Using Health and Behavior Codes at Routine Well-child Visits
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.