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U.S. Department of Health and Human Services

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

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MAZOR ROBOTICS LTD MAZOR RENAISSANCE INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number TPL0038
Device Problems Use of Device Problem (1670); Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/15/2020
Event Type  malfunction  
Manufacturer Narrative
Analysis results were not available as of the date of this report. A follow up report will be submitted when analysis is complete. 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 spinal procedure. It was reported that there was a lateral deviation of the right l5 screw during the procedure. The amount of deviation was unknown. The surgeon manually freehanded the screw during the same procedure to correct it. A 27 point accuracy test was completed for the rbt device and the device passed so the cause of the deviation was unknown. There was no patient harm and the procedure was delayed more than an hour.
 
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Brand NameMAZOR RENAISSANCE
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MAZOR ROBOTICS LTD
5 shacham street
p.o. box 3104
caesarea hefa,il 30795 67
Manufacturer (Section G)
MAZOR ROBOTICS LTD
5 shacham street
p.o. box 3104
caesarea hefa,il 30795 67
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key10123335
MDR Text Key203532964
Report Number3005075696-2020-00092
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K152041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2020
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? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2013
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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