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

Model Number	19145-01
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	08/31/2016
Additional Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since the screw placed with the aid of navigation was 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 - according to the hospital, the surgery could be completed successfully and there were no negative clinical effects for the patient due to this issue.According to the results of brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the undesired screw placement is a bent navigation reference array.In addition, the different camera viewing angles to the reference array before and after the scan, using a reference geometry that is not appropriate for this workflow, has potentially contributed to this situation.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.Despite this specific instrument has a defect, there is no indication of a general problem of the device.The according 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.- offer a replacement part for the defective reference array to this hospital.- 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
A minimally invasive spine surgery for an odontoid screw placement 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 an 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.- switched the reference array from unsterile to sterile.- used the aid of navigation to determine the according entry point and angle of the odontoid screw and placed the k-wire with the aid of navigation.- placed the screw without the aid of navigation.- performed a verification scan with an airo ct scanner to confirm correct placement of the screw and detected that the screw placement was not as intended.- replaced the screw without the aid of navigation.According to the hospital, the surgery could be completed successfully and there were no negative clinical effects for the 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: 6085379
• Report Number: 8043933-2016-00040
• Device Sequence Number: 611303
• Product Code: HAW
• UDI-Device Identifier: 04056481004620
• UDI-Public: 04056481004620
• 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): 10/22/2016

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: 19145-01
• Device Catalogue Number: 22268
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2016
• Initial Report FDA Received Date: 11/08/2016
• 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