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

Model Number TPL0059

Device Problem Imprecision (1307)

Patient Problems Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)

Event Date 01/01/2017

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 g, gigliotti m, myers d, yu a, whiting d.Single-surgeon direct comparison of o-arm neuronavigation versus mazor x robotic-guided posterior spinal instrumentation.World neurosurgery.2020.Https://doi.Org/10.1016/j.Wneu.2020.01.175.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: we sought to compare intraoperative surgical instrumentation techniques with image-guidance versus robotic-guided procedures for posterior spinal fusion.Methods: a retrospective review of institutional data collected from a single surgeon was used to compare surgical outcomes between o-arm neuronavigation and the mazor x robotic-assistance system for placement of posterior spinal instrumentation in a consecutive series of patients.Univariate statistical significance testing compared time spent in the operating room, blood loss, screw accuracy, and wound healing.Results: between january 2017 and february 2019, 46 o-arm cases (mean age 59.6 years ± 13.7 years) and 39 mazor x cases (mean age 59.5 years ± 12.4 years) were conducted.Cases were classified as degenerative, infectious, oncologic, and trauma with a mean of 4.57 and 5.43 levels operated on using o-arm neuronavigation and mazor x, respectively.Mean operative times (p = 0.124), estimated blood loss (p = 0.212), wound revision rates (p = 0.560), and clinically acceptable instrumentation placement (p = 0.076) did not demonstrate significance between the 2 groups.However, screw placement was significantly more a ccurate and precise (p = 1 × 10¿9) with robotic assistance when considering gertzbein-robbins a placement.Conclusions: although a trend toward greater accuracy was noticed with robotic technology when determining clinically acceptable screws, there was not a significant difference when compared with o-arm neuronavigation.However, robotic technology has a significant effect on both precision and accuracy in gertzbein-robbins a screw placement.Robotics does not have a clear advantage when discussing infection rates, intraoperative blood loss, or operative time.Reported events: 8 cases involved a deviation of <(><<)>4mm of breach.5 cases involved wound revisions.All cases of wound revisions resulted from post-operative drainage and dehiscence with positive cultures for infection.Intra-operatively there were no reported revisions intra-operatively.

• 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: 15805497
• MDR Text Key: 303734291
• Report Number: 3005075696-2022-00081
• 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: Physician
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 10/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention