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

Model Number TPL0038

Device Problem Use of Device Problem (1670)

Patient Problems Bone Fracture(s) (1870); Spinal Column Injury (2081)

Event Date 01/29/2018

Event Type  Injury  

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 to treat a focal deformity related to scoliosis with fixation at t3-l1.It was reported that the patient had existing fusion at t10 to l1 and the procedure was planned for an extension up to t3.The manufacturer representative planned the case on (b)(6) 2018 and the plan was approved by the surgeon prior to the procedure.The procedure was to take place in 2 segments with the clamp being used for both segments, placed at t7 for the first segment of sugery and at t5 for the second segment.The representative noted to surgeon that there should be further bridge stabilization for both segments but the surgeon confirmed the platform stability on the patient's anatomy and proceeded with the operation.For registration of the first segment, 2ap and 3obl images were required.The arm board was noted to have been in the way for the obl shot so the anaethestist supported the arm whilst the shot was being taken.Automatic segmentation was achieved and registration was successful off of t9 for t5-t9 with the exclusion of t7.T8 and t9 were sent and drilled with high level of care taken with surgical technique to address skive potentials.Registration for the second segment of surgery required 2ap and 4obl images.Automatic segmentation was achieved and registration was successful for t2-t7.However there were issues with reachability for right side trajectories t2-t6 and bilateral trajectories at t7.The surgeon drilled all left trajectories t3-t6 with high level of care taken with the surgical technique to address skive potentials.Left side trajectories at t3-t6 and bilateral t7 trajectories were not placed with the guidance system as the reachability issues required the planned trajectories to be changed too much.The surgeon decided not to send t2 because the t5 spinous process which had had the clamp attached broke off when the rbt device was placed on the head station.Therefore the final construct was up to t3.Fluro images confirmed accuracy for all screws that were placed.Surgery was delayed less than an hour.

• 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: 9711201
• MDR Text Key: 192431133
• Report Number: 3005075696-2020-00005
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K152041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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?: Yes
• 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: 01/29/2018
• Date Device Manufactured: 09/01/2016
• 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 Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 56