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

Model Number	TPL0059
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Stone l, broughton a, lewis c, pham m.Single position robot-assisted pedicle screw placement with s2-alar-iliac fixation in lateral decubitus: cadaveric feasibility study and early clinical experience.European spine surgery.30 june 2023.Https://doi.Org/10.1007 /s00586-023-07832-z abstract: objectives single position lateral fusion with robotic assistance eliminates the need for surgical staging while harnessing the precision of robotic adjuncts.We expand on this technique by demonstrating the technical feasibility of placing bilateral pedicle screws with s2-alar-iliac (s2ai) fixation while in the lateral position.Methods a cadaveric study wasperformed using 12 human specimens.A retrospective clinical series was also performed for patients who had undergone robot-assisted placement of s2ai screws in lateral decubitus between june 2020 and june 2022.Case demographics, implant placement time, implant size, screw accuracy, and complications were recorded.Early postoperative radiographic outcomes were reported.Results in the cadaveric series, a total of 126 screws were placed with robotic assistance in 12 cadavers of which 24 screws were s2ai.There were four breaches from pedicle screws and none with s2ai screws for an overall accuracy rate of 96.8%.In the clinical series, four patients (all male, mean age 65.8 years) underwent single position lateral surgery with s2ai distal fixation.Mean bmi was 33.6 and mean follow-up was 20.5 months.Mean radiographic improvements were lumbar lordosis 12.3 ± 4.7°, sagittal vertical axis 1.5 ± 2.1 cm, pelvic tilt 8.5 ± 10.0°, and pelvic incidence¿lumbar lordosis mismatch 12.3 ± 4.7°.A total of 42 screws were placed of which eight screws were s2ai.There were two breaches f rom pedicle screws and none from s2ai screws for an overall accuracy rate of 95.2%.No repositioning or salvage techniques were required for the s2ai screws.Conclusions we demonstrate here the technical feasibility of single position robot-assisted placement of s 2-alar-iliac screws in the lateral decubitus position for single position surgery.Reported events: four patients underwent a spinal procedure.Of 42 screws placed in lateral position using the robotics platform, including the eight s2ai screws, there were two, total breaches (one lateral grade 3 and one superior grade 3) in two patients for a screw accuracy of 95.2%.These were both noted on the intraoperative ct spin and repositioned using navigated techniques with no postoperative clinical symptoms.There were no s2ai screw breaches.Twelve cadavers were utilized to in spinal procedures of 124 screws placed in lateral position including 24 s2ai screws, there were four total breaches (two lateral grade 4 and two lateral grade 2) all of which were on the right-sided ¿down¿ side in two cadavers for a total screw accuracy of 96.8%.There were no s2ai screw breaches.When divided by left-sided ¿up¿ side screws and right-sided ¿down¿ side screws, 61/61 (100%) left-sided screws were placed accurately whereas 61/65 (93.8%) right sided screws were placed accurately.See attached article.
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.A.1-a.5) patient information was included in the journal.A.2.This value is the mean age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.A.4.The patient's weight was no provided.B.3.Please note that this date is based off of the date the article was published online as the event dates were not provided in the published literature.B.5.Included the article citation h.3.No evaluation was performed as the event was reported as a literature article.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MAZOR X SYSTEM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 1 haeshel street. (building c); caesarea business park; caesarea hefa,il 30798 30; IS 3079830
• Manufacturer (Section G): MAZOR ROBOTICS LTD; 1 haeshel street. (building c); caesarea business park; caesarea hefa,il 30798 30; IS 3079830
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21180832
• Report Number: 3005075696-2025-00044
• Device Sequence Number: 8545990
• Product Code: OLO
• UDI-Device Identifier: 07290109181158
• UDI-Public: 07290109181158
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male