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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 Problems Cerebrospinal Fluid Leakage (1772); Nerve Damage (1979); Unspecified Nervous System Problem (4426)
Event Date 11/23/2021
Event Type  Injury  
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.
 
Event Description
Medtronic received information regarding a guidance system being used during a spinal procedure. It was reported that there were deviations and the surgeon could not instrument due to the platform during a t3-s2 open procedure. The surgeon placed screws from left s1 to l1 and all were accurate. On right l4, there was an inferior skive and the patient lost motor control and had a csf leak. The right tib, right ehl, and right gastroc had flatlined and the surgeon was unable to get a response when stimulating. Right l5 and s1 had medial beaches of 1 cm. A neurosurgeon was called in to help repair the csf lead along with the nerves. The surgeon then tried to use the spinous process clamp on l2 and l4 to register l1-s2, but they were unable to do so they continued to the next segment. The next segment was t7-l1 and green values could not be achieved for t11 during registration. The surgeon decided to continue with the other bodies and they found that they were inferior. The surgeon decided to abort the use of the guidance system and complete the procedure freehand. The manufacturer representative believed there was a patient shift that resulted in the issues. The surgeon felt the schanz bridge mounting system had poor rigidity and the schanz connector was too bulky, which caused difficulties in reaching some trajectories. The patient's motor function had not returned after the procedure. The surgeon indicated the nerves were damaged, would not be able to be repaired and resulted in foot drop. The procedure was delayed less than 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 Key13026802
MDR Text Key286456952
Report Number3005075696-2021-00141
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 01/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2021
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 Manufacturer11/24/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/26/2019
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: 12/17/2021 Patient Sequence Number: 1
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