MAUDE Adverse Event Report: MAZOR ROBOTICS LTD MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number TPL0059

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

Please note that this date is based off the date of publication of the article as the actual event date was not provided. The reported event was from the following literature article: mao j, khan a, soliman m, levy b, mcguire m, starling r, hess r, agyei j, meyers j, mullin j, pollina j. Use of the scan-and-plan workflow in next-generation robot-assisted pedicle screw insertion: retrospective cohort study and literature review. World neurosurgery. 2021. E1-e9. Https://doi. Org/10. 1016/j. Wneu. 2021. 02. 119 if information is provided in the future, a supplemental report will be issued.

Event Description

Abstract: to report our experience using the scan-and-plan workflow and review current literature on surgical efficiency, safety, and accuracy of next-generation robot-assisted (ra) spine surgery. The records of patients who underwent ra pedicle screw fixation were reviewed. The accuracy of pedicle screw placement was determined based on the ravi classification system. To evaluate workflow efficiency, 3 demographically matched cohorts were created to analyze differences in time per screw placement (defined as operating room [or] time divided by number of screws placed). Group a had 4 screws placed, group b had 4 screws placed, and group c had >4 screws placed. Intraoperative errors and postoperative complications were collected to elucidate safety. Eighty-four ra cases (306 pedicle screws) were included for analysis. The mean number of screws placed was 2. 1 +- 0. 3 in group a and 6. 4 +- 1. 2 in group c; 4 screws were placed in group b patients. The accuracy rate (ravi grade i) was 98. 4%. Screw placement time was significantly longer in group a (101 +- 37. 7 minutes) than group b (50. 5 +- 25. 4 minutes) or c (43. 6 +- 14. 7 minutes). There were no intraoperative complications, robot failures, or in-hospital complications requiring a return to the operating room. The scan-and-plan workflow allowed for a high degree of accuracy. It was a safe method that provided a smooth and efficient or workflow without registration errors or robotic failures. After the placement of 4 pedicle screws, the per-screw time remained constant. Further studies regarding efficiency and utility in multilevel procedures are necessary. Reported events: 1. After use of the guidance system for spinal surgery to place screws, one patient developed discitis that was managed by ct-guided biopsy and antibiotics.

• Brand Name: MAZOR X SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IS 3079567
• Manufacturer (Section G): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IS 3079567
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 12985108
• MDR Text Key: 287273245
• Report Number: 3005075696-2021-00132
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 12/13/2021 Patient Sequence Number: 1