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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 Pain (1994)
Event Date 11/04/2021
Event Type  Injury  
Event Description
Medtronic received information regarding a guidance system being used during a spinal procedure. It was reported that the patient had severe pain two days after a l5-s1 tlif procure was completed. Imaging was done and the right l5 screw was deviated by 1-2 mm inferior. During the procedure, a schanz pin was placed in the right psis to mount the surgical system to the patient. A mis ct-fluoro workflow was followed. High skive potential was noted on the trajectories. The surgeon started completed the screws in the following order: left l5, left s1, right l5 and right s1. When drilling l5, the surgeon had to use excessive force to drill due to hard bone and difficulty breaking through the posterior wall. When working on left l5, the surgeon had to re-adjust during the procedure. The manufacturer representative believed the high inferior skive potential and difficulty drilling the bone contributed to the deviation. The procedure was delayed less than an hour. A revision procedure was done to remove both screws at l5. The surgeon decided not to placed screws at that position. The patient was doing well after the revision.
 
Manufacturer Narrative
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.
 
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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 Key12771070
MDR Text Key280464298
Report Number3005075696-2021-00123
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 02/23/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2021
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 Manufacturer11/04/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2017
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: 11/08/2021 Patient Sequence Number: 1
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