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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 Problem Use of Device Problem (1670)
Patient Problems Cyst(s) (1800); Discomfort (2330)
Event Date 06/14/2020
Event Type  Injury  
Manufacturer Narrative
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 to treat degenerative disc with fixation. It was reported that during a l4-s1 revision case, the right l5 screw deviated from the planned trajectory. The screw was deviated approximately two mm inferior. The manufacturer representative thought surgical technique of working on the opposite side of screw placement caused the deviation. The patient did experience some discomfort and they had developed a cyst in the same area of the screw after the surgery. The screws were repositioned on (b)(6)2020 using navigation to assist with the discomfort. The surgeon indicated that it was unknown whether it was the screw, cyst or both that caused the problem. There was no patient harm and the procedure was delayed less than an hour.
 
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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
Manufacturer (Section G)
MAZOR ROBOTICS LTD
5 shacham street
p.o. box 3104
caesarea hefa,il 30795 67
Manufacturer Contact
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10233418
MDR Text Key197598661
Report Number3005075696-2020-00099
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
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2020
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 Manufacturer07/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2017
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: 07/06/2020 Patient Sequence Number: 1
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