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U.S. Department of Health and Human Services

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

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MAZOR ROBOTICS LTD MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TPL0059
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Numbness (2415); Lethargy (2560)
Event Date 12/13/2021
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: diogo garcia d, akinduro o, de biase g, sousa-pinto b, jerreld d, dholakia r, borah b, nottmeier e, deen h, fox c, bydon m, chen s, quinones-hinojosa a, abode-iyamah k. Robotic-assisted vs nonrobotic-assisted minimally invasive transforaminal lumbar interbody fusion: a cost-utility analysis. Neurosurgery online. 90:192¿198, 2022. Doi:10. 1227/neu. 0000000000001779. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Abstract: management of degenerative disease of the spine has evolved to favor minimally invasive techniques, including nonrobotic-assisted and robotic-assisted minimally invasive transforaminal lumbar interbody fusion (mis-tlif). Value-based spending is being increasingly implemented to control rising costs in the us healthcare system. With an aging population, it is fundamental to understand which procedure(s) may be most cost-effective. To compare robotic and nonrobotic mis-tlif through a cost-utility analysis. We considered direct medical costs related to surgical intervention and to the hospital stay, as well as 1-yr utilities. We estimated costs by assessing all cases involving adults undergoing robotic surgery at a single institution and an equal number of patients undergoing nonrobotic surgery, matched by demographic and clinical characteristics. We adopted a willingness to pay of $50 000/quality-adjusted life year (qaly). Uncertainty was addressed by deterministic and probabilistic sensitivity analyses. Costs were estimated based on a total of 76 patients, including 38 undergoing robot-assisted and 38 matched patients undergoing nonrobotic mis-tlif. Using point estimates, robotic surgery was projected to cost $21 546. 80 and to be associated with 0. 68 qaly, and nonrobotic surgery was projected to cost $22 398. 98 and to be associated with 0. 67 qaly. Robotic surgery was found to be more cost-effective strategy, with cost-effectiveness being sensitive operating room/materials and room costs. Probabilistic sensitivity analysis identified robotic surgery as cost-effective in 63% of simulations. Our results suggest that at a willingness to pay of $50 000/qaly, robotic assisted mis-tlif was cost -effective in 63% of simulations. Cost-effectiveness depends on operating room and room (admission) costs, with potentially different results under distinct neurosurgical practices. Reported events: 1. One patient undergoing spinal surgery using the guidance system experienced intraoperative complications. The patient experienced a cerebrospinal fluid leak. 2. Two patients undergoing spinal surgery using the guidance system experienced post-operative infection.
 
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Brand NameMAZOR X SYSTEM
Type of DeviceORTHOPEDIC 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 Key14292153
MDR Text Key294653662
Report Number3005075696-2022-00042
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 05/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2022
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
Date Manufacturer Received04/05/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/01/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/05/2022 Patient Sequence Number: 1
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