MAUDE Adverse Event Report: BRAINLAB AG SPINE & TRAUMA 3D (VERSION 2.0); IMAGE GUIDED SURGERY SYSTEM/STEREOT

Model Number 19061-03

Device Problems Device-Device Incompatibility (2919); Compatibility Problem (2960); Data Problem (3196)

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

Event Date 03/04/2014

Event Type  malfunction  

Event Description

A spine surgery was planned to be performed with the aid of brainlab navigation software spine and trauma 3d 2.1.To perform the initial patient registration the surgeon used the automatic registration of ict data functionality, which loads an intraoperatively obtained ct image data set into the navigation software and automatically matches it to the actual patient anatomy for navigation.After performing the according ct scan with a siemens somatom definition as ct scanner and loading it into the navigation software, the automatic matching of the image data set was not successful.Instead in the are of the patient no image data set was virtually displayed in the navigation device.The automatic image registration was repeated, however with the same result.The surgeon decided to continue with the surgery without the aid of navigation.The surgery ahs been completed successfully.There have been no negative clinical effects for this specific patient reported to brainlab by the hospital.

Manufacturer Narrative

In this specific case the inaccurate matching of ct data to the actual patient anatomy was obvious for the user.The surgeon accordingly decided to complete the surgery without the aid of navigation.Although there has been no injury or any negative clinical effect for this specific patient reported to brainlab, if this malfunction would recur, a risk to patient health cannot be excluded.Brainlab investigation has shown: due to a change in the corresponding siemens data output for siemens somatom definition as ct scanner with software somaris som 7 (or higher), the information from the ct scanner cannot be correctly processed in navigation software, when using automatic gantry communication.As a result, in the navigation software the ct image data set appears shifted in the scanner movement direction.For further details, please refer to the attached product notification information.Brainlab intends the following corrective actions (concluded on (b)(6) 2014).Existing potentially affected customers receive a product notification.Brainlab will perform corresponding service visits to change the gantry communication from automat to manual, to correct for this error.

• Brand Name: SPINE & TRAUMA 3D (VERSION 2.0)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/STEREOT
• Manufacturer (Section D): BRAINLAB AG; kapellenstrasse 12; feldkirchen 8562 2; GM 85622
• Manufacturer Contact: julia mehltretter ; kapellenstrasse 12; feldkirchen 85622 ; GM 85622 ; 99915680
• MDR Report Key: 3941942
• MDR Text Key: 17989527
• Report Number: 8043933-2014-00019
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K070106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 19061-03
• Device Catalogue Number: 19061-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2014
• Initial Date FDA Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• 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