MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MAZOR RENAISSANCE; INSTRUMENT, STEREOTAXIC

Model Number TPL0038

Device Problem Output Problem (3005)

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

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation team reviewed all the acquired images and the operation log of the system.It was concluded that the cause for the multiple failed registrations is cross-view error between the ap and obl images and a low image match between the ct to fluro.The cross-view error and low image match is a result of a low quality of the images acquired during the case.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 registration filed at first attempt.The surgeon moved the 3d marker from station 5 to station 8 and a new set of images were taken.Registration did not succeed at second attempt, so a new ap image was taken.After several attempts, only t11 & t10 vertebrae were registered, so a new set of images were taken, but registration failed on all bodies with automatic, semi-automatic and manual.The surgeon decided to abort and continue free hand.There was no known impact on the patient outcome.

• Brand Name: MAZOR RENAISSANCE
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9587042
• MDR Text Key: 175393059
• Report Number: 1723170-2020-00144
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2019
• 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: N
• Patient Sequence Number: 1