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U.S. Department of Health and Human Services

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

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MAZOR ROBOTICS LTD MAZOR X SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TPL0059
Device Problem Imprecision (1307)
Patient Problem Insufficient Information (4580)
Event Date 04/21/2022
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: asm0206, serial/lot #: (b)(4), udi#: (b)(4). A medtronic representative went to the site to test the equipment. Testing revealed that surgical arm pass and accuracy, navigation and built in self test, but failed the stress test at j5. A field motor calibration of the surgical arm was done and the arm then passed all testing. The system then passed the system checkout and was found to be fully functional. 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 a l3-l5 spinal fusion case. Ct-fluoro registration and 3define scan were completed without issue. An accuracy check on the arm guide passed. After successful setup, the surgical arm was sent to left l3. The surgeon placed the screw and the neuromonitoring dipped during placement. The screw was removed and the surgeon used a pedicle finder to determine the location. After checking the hole location, the placed the screw and neuromonitoring was triggered again. The surgeon removed the screw and checked the hole with a pedicle finder again. The surgeon determined there was a lateral breach. The screw was placed manually without the surgical arm. The surgeon decided to restart the setup and registration process with the guidance system. Setup was completed without issue using two new flouro images. The surgical arm was sent to left l4 and an accuracy check was done. The surgical arm failed the accuracy check so the surgeon decided to abort the use of the guidance system and complete the procedure using navigation. The procedure was delayed over an hour.
 
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Brand NameMAZOR X 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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14245808
MDR Text Key290451311
Report Number3005075696-2022-00041
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
Report Date 05/02/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
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? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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