• 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 Problems Imprecision (1307); Unintended Collision (1429)
Patient Problems Muscle Weakness (1967); Nerve Damage (1979)
Event Date 06/22/2021
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: asm0206. A medtronic representative went to the site to test the equipment. Testing revealed that the surgical arm failed the 3 and 10 point accuracy checks. Analysis results of the software exports 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 deviation during an open t10 to pelvis procedure. When moving the surgical arm to a different trajectory during the case, the arm hit the bone mount bridge. The surgeon did an accuracy test and everything was accurate. A new snapshot was done as a precaution and navigation was accurate. A 3define scan was completed to define the work volume during the procedure. The left l1 screw was noted to be a little medial, but the surgeon thought the position was ok. After the procedure, the patient woke up with left side weakness and no movement in their left leg. The surgeon indicated there was significant neurological injury. A ct scan was done and the t10 - l1 screws on the left side were all medial. The manufacturer representative noted that the deviations were not seen on intra op imaging. The amount of deviation was unknown. All of the right side screws and l2-pelvis on the left side were placed accurately. The surgeon did not feel the system was inaccurate during the case. The surgeon was standing on the left side of the patient during the procedure. The cause of the deviation was not determined. A revision to reposition the screws was planned. There procedure was delayed less than an hour. The guidance system was tested and the surgical arm failed the 3 and 10 point accuracy tests.
 
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 Key12173576
MDR Text Key261708563
Report Number3005075696-2021-00084
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
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 Manufacturer06/24/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/15/2021 Patient Sequence Number: 1
-
-