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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAZOR ROBOTICS LTD RENAISSANCE SYSTEM INSTRUMENT, STEREOTAXIC

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MAZOR ROBOTICS LTD RENAISSANCE SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number TPL0038
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/08/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a guidance system being used during a cranial procedure. It was reported that mri was completed the day before the case. Patient received imaging while under. The representative picked up mri the day before and uploaded t1 with contrast to the workstation and t2. Once this was completed the surgeon completed a good fusion and then set ac and pc. The surgeon then set left and right gpi and his left and right entry point careful to avoid coronal suture and creating the trajectories. The trajectories were modified to ensure that they did not violet vital structures and maintained an approach within gyri. Once completed the surgeon calculated the guidance device positions. There were issues calculating a proper position, so the skin level was adjusted considerably to obtain one that worked and was suitable to the surgeon. The representative then right clicked on "fud'' markers and guidance device base reading off the locations to the "mc". The surgeon then mounted the guidance system and took a ct. The ct was then fused by the surgeon and checked by the surgeon and the representative. Leads were placed left then right. All trajectories were checked intra-operatively for accuracy and placement. Both trajectories were acceptable. The surgeon remained pleased with the system. There were very minor deviations however the trajectories still worked to stimulating the correct portions of the gpi. No patient harm was reported.
 
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Brand NameRENAISSANCE SYSTEM
Type of DeviceINSTRUMENT, STEREOTAXIC
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 Key9711778
MDR Text Key192178700
Report Number3005075696-2020-00018
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140167
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTPL0038
Device Catalogue NumberTPL0038
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 Received03/08/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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