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Analysis of root causes of adverse events with Mazor X and Mazor X stealth edition-guided spine surgeries: an FDA
Apratim Maity1, Ethan D L Brown2, Max Ward2
1Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Lake Success, USA. amaity@northwell.edu.
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.
Insights
Adverse events with Mazor X surgical robots are often due to external factors and user error, particularly affecting the lower spine. Improved surgeon training is crucial for enhancing patient safety and reducing complications.
Area of Science:
- Spinal surgery
- Robotic surgery
- Medical device safety
Background:
- The Mazor X (MX) and Mazor X Stealth Edition (MXSE) are robotic guidance systems used in spinal surgery.
- Understanding adverse events associated with these systems is critical for patient safety.
Purpose of the Study:
- To analyze adverse events linked to the Mazor X (MX) and Mazor X Stealth Edition (MXSE) robotic guidance systems.
- To identify root causes, vertebral distribution, surgical delays, robot abandonment, and patient outcomes associated with these events.
Main Methods:
- Analysis of 330 adverse events reported in the Manufacturer and User Facility Device Experience (MAUDE) database for MX and MXSE systems.
- Categorization of events based on root causes, vertebral involvement, surgical impact, and patient outcomes.
Main Results:
- External root causes predominated (35% MX, 52% MXSE), with user error being the most frequent.
- Adverse events most commonly affected the L3-L5 vertebrae, with medial or lateral deviations.
- Motor deficits were the primary outcome for MX, while sensory deficits were more common for MXSE. Two deaths were linked to MX, none to MXSE.
Conclusions:
- The MAUDE database provides valuable insights into the types and root causes of adverse events related to medical devices like the Mazor X.
- User-related errors are a significant factor in adverse events, highlighting the need for enhanced surgeon training.
- Understanding adverse event patterns and their origins is essential for improving patient safety and reducing complication rates in robotic spinal surgery.
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