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

Model Number 22260

Device Problems Use of Device Problem (1670); Misassembly by Users (3133)

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

Event Date 01/20/2015

Event Type  No Answer Provided  

Event Description

A spine surgery for a minimally invasive fusion of l4-l5 was planned to be performed with the aid of brainlab navigation system spine & trauma 3d 2.0.During the procedure the surgeon: attached the navigation reference clamp on what he regarded as spinous process of l3; placed screws on the right side of l4 and l5 with the aid of navigation; when placing the kwire on the left side of l4, noticed that the position is not as intended; performed a verification scan and detected that the screws on the right side of l4 and l5 were not placed as intended; discontinued to use the aid navigation and completed the case conventionally with using a x-ray device.The two screws placed with the aid of navigation have been removed and replaced.According to the hosp, there were no negative clinical effects for this specific patient, specifically no harm of critical structures due to the misplaced screws.The surgery, including the placement of 4 screws without the aid or navigation, could be completed successfully.

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since two screws were not placed as intended, although: there is no indication of a systematic error or malfunction of the brainlab device, corresponding measures to minimize this anticipated risk as low as reasonably practicable are in place, according to the hosp there is no negative clinical effect to the patient.According to the results of brainlab investigation and the info provided by the hosp, it can concluded that the root cause for the displaced screws is a combination of: an incorrect mounting of the reference array (in between of the spinous processes instead of mounting it directly to the spinous process).This leads to a relative movement between the reference array and the vertebras operated on, which cannot be compensated by the navigation system, a potential movement of the reference array, caused by a force applied to the array with the instrumentation, which leads to a shifted display of info in the navigation system.There is no indication of a systematic error or malfunction of the brainlab navigation device.Brainlab measures to reduce this already anticipated risk to be as low as reasonably practicable are in place.Brainlab intends to offer an additional training to this hosp.

• Brand Name: NAVIGATION SW SPINE & TRAUMA 3D (VERS. 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: 4586790
• MDR Text Key: 5447509
• Report Number: 8043933-2015-00002
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22260
• Device Catalogue Number: 22260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• 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
• Patient Outcome(s): Other