ArticleEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2026
Analysis of root causes of adverse events with Mazor X and Mazor X stealth edition-guided spine surgeries: an FDA MAUDE database study.
Article in European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Adverse events and device malfunctions in robotic thyroidectomy: a decade-long analysis of the MAUDE database.Journal of robotic surgery · 2026Article
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis study aimed to analyze adverse events associated with Mazor X surgical guidance robots, focusing on parameters such as root causes, vertebral distribution, surgical delay, robot abandonment, and more.
methods330 adverse events reported within the Manufacturer and User Facility Device Experience (MAUDE) database for the Mazor X (MX) and Mazor X Stealth Edition (MXSE) robot guidance systems were analyzed and categorized based on the root causes, vertebral distribution, surgical delay, robot abandonment, and patient outcomes.
resultsBoth the MX and MXSE adverse events were primarily due to external root causes (35% and 52%, respectively), with user error being the most common. Deviations were most likely to affect the L3, L4, and L5 vertebra, and deviate either medially or laterally. Motor deficits were the most common adverse patient outcome for MX, while sensory deficits were the most common for MXSE. There were two deaths associated with the MX, compared to zero deaths with the MXSE.
conclusionWhile 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.
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