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

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.

• 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: 14292153
• MDR Text Key: 294653662
• Report Number: 3005075696-2022-00042
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 07290109181158
• UDI-Public: 07290109181158
• 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: 05/04/2022

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: 04/05/2022
• Initial Date FDA Received: 05/05/2022
• Date Device Manufactured: 05/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention