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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAZOR ROBOTICS LTD MAZOR X STEALTH EDITION ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAZOR ROBOTICS LTD MAZOR X STEALTH EDITION ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TPL0059
Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Peripheral Nervous Injury (4414); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2020
Event Type  Injury  
Manufacturer Narrative
Other relevant device(s) are: product id: asm0206-01r, serial/lot #: (b)(4), udi#: (b)(4). A medtronic representative went to the site to test the equipment. Testing revealed that the surgical arm failed and advanced accuracy test at points 1, 3 and 5 on the left side. The accuracy pointer touched the inner wall of the divot. The surgical arm was replaced. The system then passed the system checkout and was found to be fully functional. The surgical arm was returned for analysis. 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 the patient went to the clinic over the weekend with foot drop that was potentially due to a misplaced screw. Four screws were placed during a single position olif procedure using the guidance system on (b)(6) 2020. An interbody was placed prior to placing the screws. During the procedure, the instrument on the surgeon screen did not match the instrument in relation to the patient. A second snapshot was completed to resolve the issue. The patient did not have to be re-register. No other issues occurred during the procedure. The screws looked to be matched up with the planned trajectories according to confirmation images taken during the procedure; however, after further examination, the left l5 screw was medial by 3. 5-10 mm. The initial procedure was delayed less than an hour. A revision procedure was planned to reposition the screw, but had not been scheduled.
 
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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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10885494
MDR Text Key217701599
Report Number3005075696-2020-00128
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,Followup,Followup,Followup
Report Date 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2020
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 Manufacturer10/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2018
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: 11/23/2020 Patient Sequence Number: 1
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