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 Consequences Or Impact To Patient (2199)

Event Date 09/25/2018

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since k-wires were placed in a different position in the spine than intended with the brainlab device involved, although: there is no indication of a systematic error or malfunction of the brainlab navigation device, and according brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place according to the hospital, the final outcome of the surgery was successful, there were no negative clinical effects to the patient due to this issue (also not due to surgery/ anesthesia delay of 1 hour), no (other) remedial actions were necessary/planned/done, and hospitalization was not prolonged.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the two k-wires not placed as intended is a reference clamp movement while using the pedicle access needle (due to reference clamp not stable enough mounted on the spinous process).In detail: in the minimally invasive surgery, both instruments (reference clamp and pedicle access needle) were inserted through skin (small incisions) and muscle to the bone, and were located close to each other (both on l3).When the surgeon adjusted the position of the pedicle access needle with aid of the navigation, the movement may have been transmitted to the reference clamp (by the skin and muscles), provided the reference clamp was not stable enough mounted on the spinous process.Apparently, this has not been recognized with the necessary verification if the reference was rigidly attached to the bone nor with the necessary continued verification of navigation accuracy by the user before the k-wire placement.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 re-iterate the relevant topics regarding the use of the device to this customer, and advices to discontinue use of arrays with worn teeth.

Event Description

A minimally invasive spine surgery for stabilization of l3-l4 (due to spondylolisthesis) was planned to be performed with the aid of brainlab navigation system spine and trauma 3d 2.6 (on (b)(6) 2018).During the procedure the surgeon: positioned the patient in prone position on the or table attached the radiolucent reference clamp to the spinous process of l3 (incl.The 3-sphere reference array).Performed an intraoperative scan with the ziehm vision rfd 3d c-arm, that was automatically matched by the navigation system with the current patient anatomy (automatic image registration) verified the accuracy of the registration and determined it to be appropriate placed two k-wires in l3 (left and right) with the aid of navigation (using the pedicle access needle).Obtained an x-ray image, that revealed that both the k-wires were not placed as intended.(deviation was quantified >1cm for one k-wire, 0.5 - 1 cm for the other k-wire).Decided to replace the k-wires without aid of navigation (using x-ray for verification).Placed the remaining two k-wires (in l4) and four screws (in l3 and l4) without aid of navigation (using x-ray for verification).According to the hospital, the final outcome of the surgery was successful, there were no negative clinical effects to the patient due to this issue (also not due to surgery/anesthesia delay of 1 hour), no (other) remedial actions were necessary/planned/done, and hospitalization was not prolonged.

• Brand Name: NAVIGATION SOFTWARE SPINE & TRAUMA 3D (VERSION 2.6)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer Contact: andrea miller ; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• MDR Report Key: 8022727
• MDR Text Key: 125603589
• Report Number: 8043933-2018-00039
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000493
• UDI-Public: 04056481000493
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K070106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2018

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
• Device Operator: Health Professional
• Device Model Number: 22268A
• Device Catalogue Number: 22268A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 10/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2016
• 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