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U.S. Department of Health and Human Services

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

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MAZOR ROBOTICS LTD MAZOR X ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
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Brand NameMAZOR X
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAZOR ROBOTICS LTD
5 shacham street
p.o. box 3104
caesarea hefa,il 30795 67
3079567
Manufacturer (Section G)
MAZOR ROBOTICS LTD
5 shacham street
p.o. box 3104
caesarea hefa,il 30795 67
3079567
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key9920820
MDR Text Key194363717
Report Number3005075696-2020-00082
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163221
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 04/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberTPL0059
Device Catalogue NumberTPL0059
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/03/2020 Patient Sequence Number: 1
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