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

Model Number TPL0059

Device Problem Imprecision (1307)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2021

Event Type  malfunction  

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: lee n, zuckerman s, buchanan i, boddapati v, mathew j, marciano g, robertson d, lakomkin n, park p, leung e, lombardi j, lehman r.Is there a difference in screw accuracy, robot time per screw, robot abandonment, and radiation exposure between the mazor x and the renaissance? a propensity-matched analysis of 1179 robot-assisted screws.Global spine journal.2021.1-7.Doi: 10.1177/21925682211029867.If information is provided in the future, a supplemental report will be issued.

Event Description

To compare the outcomes/complications of 2 robotic systems for spine surgery.Adult patients (b)(6) years-old who underwent robot-assisted spine surgery from 2016-2019 were assessed.A propensity score matching (psm) algorithm was used to match mazor x to renaissance cases.Preoperative ct scan for planning and an intraoperative o-arm for screw evaluation were preformed.Outcomes included screw accuracy, robot time/screw, robot abandonment, and radiation.Screw accuracy was measured using vitrea core software by 2 orthopedic surgeons.Screw breach was measured according to the gertzbein/robbins classification.After psa, a total of 65 patients (renaissance: 22 vs.X: 43) were included.Patient/operative factors were similar between robot systems (p >.05).The pedicle screw accuracy was similar between robots (renaissance: 1.1% vs.X: 1.3%, p=0.786); however, the s2ai screw breach rate was significantly lower for the x (renaissance: 9.5% vs.X: 1.2%, p = 0.025).Robot time per screw was not statistically different (renaissance: 4.6 minutes vs.X: 3.9 minutes, p=0.246).The x was more reliable with an abandonment rate of 2.3% vs.Renaissance: 22.7%, p=0.007.Radiation exposure were not different between robot systems.Non-robot related complications including dural tear, loss of motor/sensory function, and blood transfusion were similar between robot systems.This is the first comparative analyses of screw accuracy, robot time/screw, robot abandonment, and radiation exposure between the mazor x and renaissance systems.There are substantial improvements in the x robot, particularly in the perioperative planning processes, which likely contribute to the x¿s superiority in s2ai screw accuracy by nearly 8-fold and robot reliability by nearly 10-fold.Reported events: after use of the guidance system during spinal procedures, 10 pedicle screws were deviated less than 2 mm, 7 pedicle screws were deviated between 2 and 4 mm, 2 pedicle screws were deviated between 4 and 6 mm, and 3 pedicle screws were deviated more than 6 mm.2.After use of the guidance system during spinal procedures, 3 s2ai screws were deviated less than 2 mm and 1 s2ai screws was deviated more than 6 mm.3.After use of the guidance system during spinal procedures, 10 pedicle and 1 s2ai screws had to be intraoperatively repositioned due to deviations.

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.

• 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
• MDR Report Key: 12394039
• MDR Text Key: 271542997
• Report Number: 3005075696-2021-00103
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K180307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

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
• Device Operator: Health Professional
• Device Model Number: TPL0059
• Device Catalogue Number: TPL0059
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 10/14/2021
• Supplement Dates FDA Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1