• 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 Use of Device Problem (1670)
Patient Problems Muscle Weakness (1967); Pain (1994)
Event Date 08/13/2020
Event Type  Injury  
Manufacturer Narrative
Software analysis was completed. Clinical export data file was thoroughly inspected. The log file was examined with respect to all intraoperative fluoro images in order to inspect and understand procedure workflow. Fluoro images were checked and 3d registration was attempted with the registration 3d marker images utilized during the operation. Analysis reviewed the planning and noticed lateral skiving potential at l3 and l4 vertebrae. The screws were planned as cortical screws and placed on the slop of a very dense cortical bone. The registration was uploaded, performed and validated to be accurate. The case was performed as an open case and the incision performed above l4 vertebra. According to the provided intra-op fluoro image of the incision, it can be noticed that the incision provides good approach to l4, but only exposed the lower portion of l3. If no additional incision was performed, a soft tissue pressure would apply on the tools and can cause the screws to deviate. Bone mount bridge was used, and no major issues were detected. Analysis inspected all provided information and concluded that the most probable causes for the deviations at l3 left and right and l4 right was skiving of the tools on the bone and soft tissue pressure due to small incision. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a guidance system being used intra-operatively of a spinal procedure. It was reported that a screw deviation was discovered. The screws were implanted during a l3-l4 case on (b)(6) 2020 with no issues. The site had taken ap shots to confirm screw placement after the case; however, they were unable to identify the deviation from those shots. On (b)(6) 2020, it was discovered that there was a deviation when the pa did a follow up visit with the patient since they were still experiencing nerve pain and weakness in their legs. It appears that the left and right l3 screws are lateral by 6 mm and are not within the pedicle. The right l4 is lateral by 6 mm. Both measurements are approximate from the distal end of the screw. The revision procedure had not been scheduled. The initial procedure was not delayed.
 
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
3079567
Manufacturer (Section G)
MAZOR ROBOTICS LTD
5 shacham street
p.o. box 3104
caesarea hefa,il 30795 67
3079567
Manufacturer Contact
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10449825
MDR Text Key204251692
Report Number3005075696-2020-00106
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K182077
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 08/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2020
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 Manufacturer08/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2018
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: 08/25/2020 Patient Sequence Number: 1
-
-