Analysis of root causes of adverse events with Mazor X and Mazor X stealth edition-guided spine surgeries: an FDA MAUDE database study

While the MAUDE database cannot be used to calculate the incidence or prevalence of adverse events, it provides insight into the types of adverse events that tend to occur with medical devices. MAUDE reports suggest that user-related errors account for most of the adverse events that occur, underscoring the need for focused surgeon training. Our study highlights the importance of understanding both the types of adverse events and their root causes to promote patient safety and reduce complication rates.