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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 Problems Imprecision (1307); Connection Problem (2900)
Patient Problems Cerebrospinal Fluid Leakage (1772); Urinary Retention (2119); Unspecified Nervous System Problem (4426)
Event Date 04/20/2021
Event Type  Injury  
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. Testing revealed no failures. The system then passed the system checkout and was found to be fully functional. Analysis results for the software exports 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.
 
Event Description
Medtronic received information regarding a guidance system being used during a spinal procedure. It was reported that the ct scan was not uploading to the guidance system so a scan <(>&<)> plan procedure was done. During the procedure, the surgeon placed screws in the following order: right l3, right l4, left l3 and left l4. The surgeon then proceeded to place sextant wires. The surgical arm was sent to the trajectory for the disk space between l3/l4. The surgeon drilled, tapped, placed a wire and then moved the surgical arm to the clear right position. The surgeon dilated over the wire, placed a 12 mm tube and connected to a bionic arm retractor. The manufacture representative noted that the bionic arm retractor wasn't working properly and needed an hour to adjust the retractor several times. The surgeon used a 9 mm acorn midas bit placed through the 12 mm tube and surgical arm. Drilling was watched using fluoro. Shots were taken throughout and all wires were clear and within the pedicle. The surgeon then implanted a flare hawk cage, followed by screws. The surgeon indicated that there was a dural tear that had to be repaired. Several post-op cts were done and the surgeon confirmed the screws looked good. The representative noted that the surgeon did not mallet the drill guide, which could have i increase the skive potential. The representative noted that the wire at right l4 was removed too early and the screw may have be a bit lateral. Several days after the case, the patient experienced bi-lateral foot drop. The surgeon thought the symptoms were caused by a "glitch" of the guidance system and a scan <(>&<)> plan procedure was not as accurate as ct to fluoro procedures. A revision procedure was done to repair the dural tear and remove hardware from the patient's right side that was deviated less than 3. 5 mm. The procedure was delayed over 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
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 Key11821980
MDR Text Key258643657
Report Number3005075696-2021-00057
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,Followup
Report Date 05/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2021
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 Manufacturer04/26/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2019
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: 05/13/2021 Patient Sequence Number: 1
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