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U.S. Department of Health and Human Services

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

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MAZOR ROBOTICS LTD MAZOR X ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TPL0059
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/17/2019
Event Type  malfunction  
Manufacturer Narrative
Export files have been received however, analysis has not yet been completed. 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 an inaccurate screw placement. During a t9 down to l2 percutaneous case, they did two registrations because they split the ct up. The first was t9 to l1, then the second went down to l2. The first registration looked good but when they moved down to l2, the left screw was placed medial and the right screw was also placed medial (in the pedical, but medial). Troubleshooting involved recalibrating the c-arm. The issue extended the surgical time by less than 1 hour. The amount of deviation was unknown.
 
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Brand NameMAZOR X
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAZOR ROBOTICS LTD
5 shacham street
p.o. box 3104
caesarea hefa,il CO 30795 67
3079567
Manufacturer (Section G)
MAZOR ROBOTICS LTD
5 shacham street
p.o. box 3104
caesarea hefa,il CO 30795 67
3079567
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key9586661
MDR Text Key175393395
Report Number1723170-2020-00140
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163221
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
Report Date 03/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2020
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 Manufacturer12/17/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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