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

Model Number TPL0038-02

Device Problem Use of Device Problem (1670)

Patient Problem Spinal Column Injury (2081)

Event Date 05/16/2018

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 degenerative disk disease with fixation at l4-l5.It was reported that planning was done by the surgeon prior to the case.A clamp with an extension was used to secure the surgical system to the patient at the l4 spinous process.Three ap and five obl images were taken.Registration was successful on the first attempt with the complex algorithm.Right l4 was sent and drilled with care taken to the surgical technique.Fluoro imaging showed that the screw was accurate.When moving the rbt to right l5, the surgeons noticed that the clamp platform was moving.It was physically confirmed that the platform had become loose and shifted too much to continue under the same registration.Upon further investigation, the surgeons highlighted that the top of the l4 spinous process had broken off, which caused the shift in the platform.At this point, the surgeons aborted use of the system and completed the surgery using a different surgical system.The procedure was not delayed for more 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: 9711170
• MDR Text Key: 192190750
• Report Number: 3005075696-2020-00003
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TPL0038-02
• Device Catalogue Number: TPL0038-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 02/14/2020
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 97