• 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 X STEALTH EDITION ORTHOPEDIC STEREOTAXIC INSTRUMENT

  • 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 X STEALTH EDITION ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TPL0059
Device Problem Imprecision (1307)
Patient Problem Pain (1994)
Event Date 11/17/2020
Event Type  Injury  
Manufacturer Narrative
Analysis of the clinical exports and logs was completed. During the analysis, the clinical export data file was thoroughly inspected. The export file was generated by the mazor x system, and includes records of all the data that was used and generated by the system during the case, including but not limited to the intra-operative scans, preoperative planning, procedure actions that were executed, and the log text file. The log text file is a chronologic documentation of the software during operation, including trajectories sent by the system, star marker (sm) recognition accuracy, etc. The log file was examined with respect to all intraoperative fluoro images to inspect and understand procedure workflow. O-arm images were checked, star marker recognition was attempted with the registration, star marker images utilized during the operation on a mazor x r d workstation. Analysis reviewed the planning made for the case. A planning of l4-l5 tlif procedure was done for the specific segment. It seems that the trajectories planned in both l4 and l5 vertebras are very proud and placed in anatomical areas which have high chance of skiving potential. The nature of the deviation was reviewed. It was reported that during a t5-l4 tlif procedure, after placing the screws and doing a spin - l4 trajectories were thought to be slightly lateral and the patient experienced right side back pain. Observing the planning of l4 and l5 from axial views, it is shown that the planned trajectories are very proud (wide) and their location is sub optimal in an anatomical area with high potential for skiving. Analysis reviewed all available information and concluded the root cause of the deviations is sub-optimal planning, resulted in skiving potential for both l4 and l5 vertebras. 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 were technical issues during a right left l4-l5 tlif procedure. The surgeon drilled pilot holes for all trajectories using a percutaneous technique. Screws were then placed. A post-op spin was done and the screws at l4 were found to be suboptimal and was slightly off by about 3. 5 mm. The screws were slightly lateral and could have affected the rigidity of the construct. Troubleshooting during the initial procedure included checking landmarks. The patient experienced right side back pain. A revision procedure was done and the screws were reposition freehand. The suspected cause of the deviation was skiving and non-optimal entry planning. The procedure was delayed less than an hour.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMAZOR X STEALTH EDITION
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 Key11453999
MDR Text Key249709145
Report Number3005075696-2021-00031
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K182077
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTPL0059
Device Catalogue NumberTPL0059
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2018
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: 03/10/2021 Patient Sequence Number: 1
-
-