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 · 2025
Analysis of root causes of adverse events with Mazor X and Mazor X stealth edition-guided spine surgeries: an FDA MAUDE database study.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Maity Apratim, Brown Ethan D L, Ward Max, Orsino Emily A, Schneider Daniel M, Sciubba Daniel M, Lo Sheng-Fu Larry
Аннотация
PURPOSE: This 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.
METHODS: 330 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.
RESULTS: Both 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.
CONCLUSION: 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.
METHODS: 330 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.
RESULTS: Both 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.
CONCLUSION: 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.