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U.S. Department of Health and Human Services

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

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MAZOR ROBOTICS LTD MAZOR X STEALTH EDITION SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TPL0059
Device Problems Imprecision (1307); Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/23/2020
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: pn: asm0206-01r, sn/ln: unk. A manufacturer representative went to the site to test the guidance system. It was found that one of the arm guides was bent thus causing the accuracy pointer to rub against the inner edge of the hole resulting in a failed test. If information is provided in the future, a supplemental report will be issued.
 
Event Description
2medtronic received information regarding a guidance system being used during a spinal procedure. It was reported that while sending the surgical arm to a trajectory, the trajectory was superior by 1. 5 mm. A surgical arm accuracy check was done in the divot on the system and the anatomy and navigation was accurate. When sending the surgical arm back to the trajectory, the surgeon said they were fighting the arm to get it in the correct trajectory. The cause of the trajectory being off was not determined. An accuracy test was completed after the case and the accuracy pointer was hitting the rim of the divot and then sliding into the divot on the arm. The surgical arm failed the advanced accuracy test. There was no patient harm and the procedure was delayed less than an hour. Additional information was received stating that we were using the guidance system to place screws. The screws were showing as superior on navigation, and felt this way to the surgeon during operation. He used counterpressure to place screws and ultimately, they proved to be accurate. The case was completed successfully.
 
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Brand NameMAZOR X STEALTH EDITION SYSTEM
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10880203
MDR Text Key228436413
Report Number3005075696-2020-00127
Device Sequence Number1
Product Code OLO
UDI-Device Identifier07290109183213
UDI-Public07290109183213
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
Report Date 03/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
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 Manufacturer12/11/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/20/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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