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); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

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

Event Date 03/16/2017

Event Type  malfunction  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since k wires were placed different than intended and a screw was placed into the spinal canal, with the brainlab device involved, despite according to the surgeon: -the screw was taken out and the procedure was finished.The dura of the spinal cord remained intact and was not ruptured.-there were no negative effects to the patient during the procedure/after procedure due to this issue.-there are no ongoing/remaining negative clinical effects for this patient post-surgery.-there was also no negative clinical effect to patient due to prolonged anesthesia (of ca.60 mins).- no other remedial actions are necessary, done or planned for this patient (other than the screw correction at the same surgery).According to the results of this technical investigation and the information provided by the hospital, it can be concluded that the root cause of the k wires placed different than intended and the screw placed into the spinal canal is that the navigation reference array was placed at the iliac crest whereas the region of interest was far away at t5, not allowing for a rigid connection of the reference array to the region of interest as required.Further contributing factors are: -the likelihood of relative movement of the vertebra was further increased due to the diagnosis of a tumor affecting the vertebrae t7 and t8 which destabilizes the whole spine.-furthermore, a decent amount of force was required to re-insert the k-wire at t5, pushing the vertebra.-the re-position of the k-wire was verified with a 2d c-arm only, and since the screws were inserted without navigation, screw placement itself could not be double-checked with the aid of navigation.There is no indication of a systematic error or malfunction of the brainlab device (navigation).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.

Event Description

A percutaneous stabilization surgery on the thoracic spine for a fusion of t5-t10 was performed with the aid of the virtual display by the brainlab navigation software spine & trauma 3d 2.6.The surgeon had planned on stabilizing t5-t10 by placing a total of 8 screws; in t5, t6, t9 and t10.The surgeon planned on using schanz screws in the hip and attaching the reference array for the navigation there.Brainlab personnel present in the case discussed and explained that having the reference array attached that far away from where it was planned to operate on is problematic for use with navigation, and suggested making a small midline incision and using the spinous process clamp (allowing also rigid connection to the region of interest).During the procedure the surgeon: · decided to place the navigation reference array on the hip, not wanting to make a midline incision due to the condition of the patient.After placing the array, an intra-operative ct scan was performed.· verified and accepted the automatic registration of the current patient anatomy to the navigation.· calibrated the brainlab pedicle access needle for navigation and used it to place the 8 k wires.After the k wires were placed, another intra-op ct was performed to verify the position of the k wires.· determined that one of the k wires on t5 was a little more lateral and another k wire was a little more deep than desired.A new intra-op ct was performed to re-register the current patient anatomy to the navigation.· planned to pull the k wire out of t5 completely and reposition it medially.The other k wire was pulled back slightly without use of navigation, but not pulled out completely.· used the pointer to touch multiple other k wires for correspondence on the navigation screen to re-verify accuracy.· attempted to reposition the pedicle access needle medially on t5, the pedicle access needle continued to go down the previous hole (which was slightly lateral).This was also confirmed by navigation, as the pedicle access needle appeared to be right where the k wire was in the intra-op scan.· eventually was able to position the pedicle access needle more medially, after a "decent amount of force" was applied.X-ray (not full ct) was used to confirm the position of the pedicle access needle.· proceeded to place cement and screws following the 8 k wires in place without further use of navigation.Another scan was then taken which showed the repositioned screw (t5) in the spinal canal.The dura of the spinal cord remained intact and was not ruptured.· the screw was taken out and the procedure was finished, with the patient having 4 screws on one side with a stabilization rod and 3 screws on the other side with a stabilization rod.According to the surgeon: -there were no negative effects to the patient during the procedure/after procedure due to this issue.-there are no ongoing/remaining negative clinical effects for this patient post-surgery.-there was also no negative clinical effect to patient due to prolonged anesthesia (of ca.60 mins).- no other remedial actions are necessary, done or planned for this patient (other than the screw correction at the same surgery).

• 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: markus hofmann ; olof-palme-strasse 9; münchen, 81829 ; GM 81829 ; 89 9915680
• MDR Report Key: 6484804
• MDR Text Key: 72500936
• Report Number: 8043933-2017-00011
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481106591
• UDI-Public: 04056481106591
• 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: Health Professional
• Type of Report: Initial
• Report Date: 03/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 22268A
• Device Catalogue Number: 71116A
• Device Lot Number: SW V. 2.6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2016
• 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