MAUDE Adverse Event Report: BRAINLAB AG NAVIGATION SOFTWARE SPINE & TRAUMA 3D (VERSION 2.5); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number	22268
Medical Device Problem Codes	Mechanical Problem (1384); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2016
Additional Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since the screws placed with the aid of navigation were not placed as desired and therewith could, in a worst case scenario, lead to harm of the spinal cord and/or main blood vessels, although: there is no indication of a systematic error or malfunction of the brainlab device.Corresponding measures to reduce this anticipated risk as low as reasonably practicable are already in place.There have been no corrective actions performed for this specific patient and there are no negative clinical effects for this patient due to this issue.Brainlab investigation could neither confirm nor disprove an actual inaccuracy and/or a contribution of the navigation to the less than ideal screw placement, especially since the screws have been placed with a non-navigated screw driver.According to the results of brainlab investigation and the information provided by the hospital, it can be concluded that a potential root cause for the undesired placement is the different camera view angle to the reference array before and after the scan in combination with a potentially bent navigation reference array.Apparently the resulting shift between virtually displayed data and the actual patient anatomy was not detected during the required accuracy verification to be performed by the user.There is no indication of a systematic error or malfunction of the brainlab navigation device.Corresponding brainlab measures to reduce this already anticipated risk to be as low as reasonably practicable are in place.Brainlab intends to: inform this hospital about the investigation results.Corresponding to the root cause, brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.
Event or Problem Description
An open spine surgery on the vertebras c2-t2 was planned to be performed with the aid of brainlab navigation system spine & trauma 3d 2.5.During the procedure the surgeon: fixated the patient's head in a third party head clamp and attached the navigation reference array to the head clamp.Performed an automatic image registration (matching of virtual display of patient image data and actual patient anatomy) in combination with the airo ct scanner.Rotated the patient table by 90 degree and moved the navigation camera from the foot to the head side of the table.Verified the accuracy of the registration and determined it to be appropriate.Used a navigated drill guide to prepare the screw canals on c2.Placed the screws with a non-navigated screw driver.Completed the surgery as planned (without further usage of the brainlab navigation system).After the surgery, the surgeon realized that the placement of the screws was not as desired.There have been no corrective actions performed for this specific patient and there are no negative clinical effects for this patient due to this issue.

• Brand Name: NAVIGATION SOFTWARE SPINE & TRAUMA 3D (VERSION 2.5)
• Common Device Name: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622
• MDR Report Key: 5989832
• Report Number: 8043933-2016-00036
• Device Sequence Number: 542131
• Product Code: HAW
• UDI-Device Identifier: 04056481000714
• UDI-Public: 04056481000714
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K070106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2016

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?: No
• Operator of Device: Physician
• Device Model Number: 22268
• Device Catalogue Number: 22268
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2016
• Initial Report FDA Received Date: 09/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other