Characterizing the complication profile of spinal robotic systems: A MAUDE analysis of device failures and associated complications by device manufacturer and brand name

Abstract

Introduction

Pedicle screw placement in spinal surgery has evolved to incorporate increased use of technology for both preoperative planning and intraoperative guidance. In recent years, robotic guidance has been used to increase the precision, accuracy, and overall patient safety of spinal column fixation via screw placement. Within this context, the present study aims to quantify and classify complications of spinal robotic devices using a nationally representative database.

Methods

The Manufacturer and User Facility Device Experience (MAUDE) was queried for adverse events involving the most widely used spinal robotic devices from inception to November 3rd, 2023. Entries were tabulated by assigning categorical variables based on event information.

Results

The query yielded 339 unique robotic failure events. The most frequent complications in robotic-assisted spinal surgeries were imprecision (73.6%), software errors (13.7%), and damaged or missing screws (4.9%). Most reported events occurred intraoperatively after the initial incision (78.5%) [compared to preoperatively or postoperatively]. The Mazor X™ system was the most represented spinal robotic platform in terms of complications, accounting for 71.6% of reported robotic failure events. Most reported errors were resolved intraoperatively or continued through the employment of alternative imaging methods and, overall, had minimal clinical significance. With respect to robot-assisted pedicle screw placement, medial breaches were 1.7x more common than lateral breaches across all robotic systems. Finally, regarding the impact of device failures on perioperative timing, we found that 10.3% of adverse events resulted in delays greater than 1 h.

Conclusion

Ultimately, imprecision and unresponsive software were found to be two of the most frequent complications of robot-assisted spine surgery. Though most reported errors were circumvented intraoperatively through conventional, non-robotic imaging/guidance methods, 10.3% of adverse events resulted in procedural delays of greater than 1 h.