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 05/23/2018

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 planned prior to surgery for two vertebrae on levels l4 - l5.Attention was paid to axial angles and skin incisions.The bed mount was chosen for this case due to clinical indication and surgeon preference.Auto segmentation was achieved using basic algorithm acquiring good values at l4 but a value greater than 1.3 at l5.The representative went back and made manual adjustments to segmentation lines.Great values were then acquired at both levels.All trajectories were sent, and wires were placed.Images were taken and both l4 wires were very low.The surgeon continued to place l5 screws and free handed both l4 screws.Surgeon was pleased with final images.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: 9712556
• MDR Text Key: 192177665
• Report Number: 3005075696-2020-00057
• 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: 05/23/2018
• Date Device Manufactured: 07/01/2013
• 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: 41 YR
• Patient Weight: 104