• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAZOR ROBOTICS LTD MAZOR RENAISSANCE 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 08/31/2020
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 to treat degenerative disc and spondylolisthesis with fixation use screws and rods. It was reported that registration was completed successfully during the procedure. When the cannula was placed, it was more than a few millimeters superior. The patient was re-registered, but the issue was not resolved. The surgeon took the mount apart, put it back together and registered the patient again, but the issue was not resolved. The trajectory was still inaccurate. The surgeon decided to abort the use of the guidance system. An 27 point accuracy test was completed after the case and the system passed. There was no patient harm and the procedure was delayed less than an hour.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10587095
MDR Text Key208555276
Report Number3005075696-2020-00111
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/25/2020
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 Manufacturer08/31/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-