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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAZOR ROBOTICS LTD RENAISSANCE SYSTEM INSTRUMENT, STEREOTAXIC

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MAZOR ROBOTICS LTD RENAISSANCE SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number TPL0038
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/27/2018
Event Type  malfunction  
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. It was reported that the case was for 14 vertebrae on levels t6 ¿ s2. The plan was done and approved by the surgeons prior to the case. The operative region was split into three segments. For segment one the clamp was placed on l4 to execute l4 - s2. For segment two the clamp was placed on l2 to execute t12 - l3. In segment three the clamp was placed on t8 to execute t6 - t11. During segment one registration manual placement of the green markers was required to successfully register l4 - s2. Auto segmentation and registration for segment two was successful off l3. Adjustment of several trajectories was required due to reachability issues. Auto segmentation and registration of segment three was successful off t11. Several screws required adjustment of trajectories due to reachability issues. All screw trajectories were sent and drilled with a high level of care. All k-wires for segment one were placed without any issues. All k-wires for segment two were placed. Fluoro images showed the k-wires at right l1 and t12 were anterior to the vertebral body. These were retracted and screws placed without issue. There was a medial deviation of the t12 k-wire. The surgeon decided to redirect this free hand. When instrumenting segment three, t11 right was not reachable in a clinically acceptable trajectory. The surgeon decided that he will free hand this trajectory. The remaining trajectories were sent and drilled with a high level of care. No patient harm was reported.
 
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Brand NameRENAISSANCE SYSTEM
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MAZOR ROBOTICS LTD
5 shacham street
p.o. box 3104
caesarea hefa,il 30795 67
3079567
Manufacturer (Section G)
MAZOR ROBOTICS LTD
5 shacham street
p.o. box 3104
caesarea hefa,il 30795 67
3079567
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key9711140
MDR Text Key192186472
Report Number3005075696-2020-00002
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K120812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 02/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTPL0038
Device Catalogue NumberTPL0038
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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