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

Model Number TPL0059

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Discharge (2225); Post Operative Wound Infection (2446)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: 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 alexander, whitin d.Single-surgeon direct comparison of o-arm neuronavigation versus mazor x robotic-guided posterior spinal instrumentation.World neurosurgery.2020.E1-e8.Doi: 10.1016/j.Wneu.2020.01.175.If information is provided in the future, a supplemental report will be issued.

Event Description

Abstract: to compare intraoperative surgical instrumentation techniques with image-guidance versus robotic-guided procedures for posterior spinal fusion.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.Between january 2017 and february 2019, 46 o-arm cases and 39 mazor x cases 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, estimated blood loss, wound revision rates, and clinically acceptable instrumentation placement did not demonstrate significance between the 2 groups.However, screw placement was significantly more accurate and precise with robotic assistance.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: it was reported that wound revisions occurred in 5 of the robot-assisted cases.All cases of wound revision resulted from postoperative drainage and dehiscence with positive cultures for infection.

• Brand Name: MAZOR X
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IL 3079567
• Manufacturer (Section G): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IL 3079567
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9920820
• MDR Text Key: 194363717
• Report Number: 3005075696-2020-00082
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 04/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention