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

Model Number TPL0038

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/31/2020

Event Type  malfunction  

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.

Event Description

Medtronic received information regarding a guidance system being used during a spinal procedure to treat degenerative disc and spondylolisthesis with fixation use screws and rods. It was reported that registration was completed successfully during the procedure. When the cannula was placed, it was more than a few millimeters superior. The patient was re-registered, but the issue was not resolved. The surgeon took the mount apart, put it back together and registered the patient again, but the issue was not resolved. The trajectory was still inaccurate. The surgeon decided to abort the use of the guidance system. An 27 point accuracy test was completed after the case and the system passed. There was no patient harm and the procedure was delayed less than an hour.

• Brand Name: MAZOR RENAISSANCE
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67
• Manufacturer (Section G): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67
• Manufacturer Contact: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10587095
• MDR Text Key: 208555276
• Report Number: 3005075696-2020-00111
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: TPL0038
• Device Catalogue Number: TPL0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse