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

Model Number TPL0059

Device Problem Imprecision (1307)

Patient Problems Unspecified Infection (1930); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

B.3.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: prod'homme m, didier g, akiki a, dietrich g, müller j, boscherini d.Mazor x stealth versus o-arm navigation for pedicle screw insertion: preliminary results of the rgnv trial on the first 100 patients.Global spine journal.2023.13:2 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Abstract: computerized navigation is currently wide spreading around the world in spine surgery, aiming to allow more accurate and safe procedures.Since the end of the 20th century, navigation appeared to be superior to traditional free-hand technique to insert pedicle screws.Thus its use is becoming a gold standard in many facilities.Robotic guidance aims to stabilize a robotic arm after surgical planning of screw trajectory.The mazor x stealth is a recent device which combines robotic guidance and navigation.The aim of the study was to compare operative and radiologic results and also radiation exposure between the mazor x stealth and the o-arm navigation for pedicle screw insertion.Material and methods: all patients who required pedicle screw insertion for posterior lumbar fusion were prospectively included and divided into two groups: rg when operated with the mazor x stealth, and nv when operated with the o-arm and navigation as a control group.Age, operative data such as number of levels operated, number of screws inserted, operative time in minutes (min), estimated blood loss (ebl in milliliters, ml), time to insert screws (in min).Satisfaction of screw positioning was assessed with the gertzbein-robbins classification.Dosimetric data of the imaging devices were collected for calculation of the effective dose e (in millisievert, msv) for the whole procedure according to the international commission on radiological protection using conversion factors.The absolute risk of cancer (ar, in %) equivalent to a whole-body acquisition was also calculated.Intraoperative and postoperative complications were recorded.Results: 100 patients were included, 50 in each group.Mean age was similar: 72 versus 69 in groups rg and nv respectively, p = 0.21.227 vertebrae were operated: 106 in group rg and 121 in group nv.A total of 438 screws were inserted, 205 in group rg and 233 in group nv.Operative time was similar between the groups, with 161 versus 151 minutes in rg and nv respectively (p = 0.37), as well as ebl (350 versus 454 ml, p = 0.13).Mean time to insert screws was significantly lower in group rg, with 13 minutes versus 18 minutes in group nv, p = 0.03; but time per screw was similar: 3.4 versus 3.8 respectively, p = 0.11.96.6% screws were satisfactory in group rg versus 98.7% in group nv.Overall e was significantly higher in group rg, with 7.24 and 5.77 msv in group nv, p <(><<)> 0.01, as well as ar, with 3.6x10-4% in rg and 2.9x10-4% in nv groups (p <(><<)> 0.01).Overall complication rate was 26% in the rg group and 36% in the nv group.Conclusion: the mazor x stealth showed pr omising results especially in accuracy of pedicle screw insertion, operative parameters and also complications, but was inferior to the o-arm navigation in terms of radiation exposure.Reported events: 1- 96.6% screws were satisfactory in group rg.2- overall complication rate was 26% in the rg group.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received stating that the complications were not related to the guidance system.There were current complications such as dural tear, infections etc.Four procedures assisted by the guidance system were aborted because of system failure.There were 7 screws deviated between 2 to 4 mm and 1 more than 6 mm.The deviated screws were stated to likely not be due to the system.The open approach leaded to excessive soft tissue retraction and then rotation of the targeted vertebra and misplacement of the screws.The use of percutaneous approach partially solved this problem, with only 1 remaining screw deviated of 2 to 4 mm despite percutaneous approach.The trajectory is not deviated in the system itself.Analysis of the errors concluded that the absence of initial surface drilling of the bone leaded to potential skiving, and in consequence misplacement of the screw despite percutaneous approach.The healthcare professional thinks that this skiving issue would be solved if the first bone cortex could be flattened first before screw trajectory preparation.

• 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: 17655104
• MDR Text Key: 322332828
• Report Number: 3005075696-2023-00045
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K182077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other