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

Model Number TPL0038

Device Problem Insufficient Information (3190)

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

Event Date 08/06/2018

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 two vertebrae on level l4 - l5.There were no issues with attachment.During registration, new images were taken in order to get registration.L5 was registered on first registration but l4 was greater than 1.3.L5 left was superior and plan was adjusted accordingly at l5 left.L4 left was also superior.The whole plan was adjusted accordingly.All neuromonitoring values were over 20.No patient harm was reported.

• Brand Name: RENAISSANCE SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IL 3079567
• Manufacturer (Section G): MAZOR ROBOTICS LTD; 5 shacham street; p.o. box 3104; caesarea hefa,il 30795 67; IL 3079567
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9712094
• MDR Text Key: 204720733
• Report Number: 3005075696-2020-00032
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TPL0038
• Device Catalogue Number: TPL0038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2018
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 78 YR