MAUDE Adverse Event Report: BRAINLAB AG NAVIGATION SOFTWARE SPINE & TRAUMA 3D (VERSION 2.6); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22268A

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

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

Event Date 06/30/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since k-wires were placed in another position than intended with the brainlab device involved, 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 already in place.According to the hospital, the outcome of the surgery was successful as intended and there were no negative clinical effects to this patient due to this issue; no further remedial actions (besides replacement of k-wire in l5 right) were reported that would have been necessary.According to the results of brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the k-wires not placed as intended is an inadequate placement of the navigation reference system, leading to a discrepancy between the virtual display of navigation and the actual patient anatomy.Details: schanz pins were not inserted far enough into the bone (since the patient was obese), so that a movement of the reference array due to pulling tissue (muscles, skin) likely occurred.Apparently this movement was not detected during continuous accuracy verification to be performed by the user throughout the procedure.Further contributing factors: a relative movement of the vertebra l5 in relation to sacrum / iliac crest that could not be compensated by the navigation system, since the reference array was not placed on the vertebra to be operated on.Patient movement during scanning (since patient's breathing was not stopped), leading to a patient registration that was less accurate than desired for this specific patient/surgery.There is no indication of a systematic error or malfunction of the brainlab navigation device.Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already 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 Description

A minimally invasive spine surgery for stabilization of l5-s1 was planned to be performed with the aid of the brainlab navigation software spine & trauma 3d 2.6.During the procedure the surgeon: positioned the patient in prone position.Attached the navigation reference array to the iliac crest, with the brainlab 2-pin bone fixator.Verified and accepted the automatic patient registration (matching of virtual display of preoperative image dataset and actual patient anatomy).Placed four k-wires (diameter 1.8mm) in l5-s1 with the aid of navigation.Obtained an intraoperative scan to verify the k-wire placement.Realized that the k-wire in l5 (right) was closer to the foramen (passageway through which nerve roots exit the spinal column) than desired.Detected a general deviation of all k-wires in caudal direction by 1-2mm.Verified and accepted the automatic patient registration (based on the intraoperatively obtained scan).Replaced the k-wire in l5 (right) with the aid of navigation.Confirmed that the k-wire placement was accurate using a c-arm.Placed the screws without aid of navigation.According to the hospital, the surgery was delayed approx.15 minutes and despite there was an increased risk to harm critical structures, the outcome of the surgery was successful as intended and there were no negative clinical effects to this patient due to this issue.No further remedial actions (besides replacement of k-wire in l5 right) were reported that would have been necessary.

• Brand Name: NAVIGATION SOFTWARE SPINE & TRAUMA 3D (VERSION 2.6)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622
• Manufacturer (Section G): BRAINLAB AG; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622
• Manufacturer Contact: andrea miller ; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622 ; 89 9915680
• MDR Report Key: 5821689
• MDR Text Key: 50390711
• Report Number: 8043933-2016-00026
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22268A
• Device Catalogue Number: 71116A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• 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
• Patient Outcome(s): Other