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U.S. Department of Health and Human Services

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

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MAZOR ROBOTICS LTD MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
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Brand NameMAZOR X SYSTEM
Type of DeviceORTHOPEDIC 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 Key12985108
MDR Text Key287273245
Report Number3005075696-2021-00132
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182077
Number of Events Reported1
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 Received12/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTPL0059
Device Catalogue NumberTPL0059
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/27/2021
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
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