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 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since screw placed differently than intended, with the brainlab device involved, despite 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 due to this issue - there were no negative clinical effects to this patient due to prolonged surgery/anesthesia (less than 10 minutes) - no other remedial actions or additional surgery are necessary, done or planned for this patient for this issue (other than repositioning of screw during this same procedure).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 screw placed differently than intended is -reference movement: one pin of the 2-pin reference was not sitting in bone leading to an instable fixation resulting in a reference movement.As the region of interest was far away from the position of the reference fixation, a small movement of the reference will have a larger effect at the region of interest -relative movement of the vertebra l1 in relation the iliac crest: as the reference array was mounted to the iliac crest and navigation was used up to l1 and l2, it is very likely that relative movements of the region of interest compared to where the reference array was attached to were present (e.G.While placing screws to l1 and therefore applying pressure to the bone, the vertebra l1 moves but not the reference mounted at the iliac crest).The indication "spondylolisthesis" increases the likelihood of relative movement further as the spine is already unstable.In such a scenario, each of these causes of reference array movement, whether independent or combined, can lead to a deviation in the navigation display compared to reality.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

Surgeon performed an l1-l2 spine fusion using brainlab devices curve and airo.A 2-pin fixator was attached to the left iliac crest.An intra-op scan at 50% lumbar dose was performed using airo.Air accuracy was good.Surgeon proceeded to put screws in l1 and l2 on the left side.He then went to navigate on the right side and noticed that the accuracy of navigation was off.He felt the accuracy was incorrect by 1 cm.Another scan was performed at 30% lumbar dose.Air accuracy was good.When surgeon looked at the screws on the left side, he noticed that the l1 screw was more medial than his original trajectory.He removed the screw and placed it back in a new trajectory.He then proceeded to place k-wires in l1 and l2 on the right side; decompressed and placed a cage in l1-l2 disc space.After placing the cage he placed the final two screws on the right side.A confirmation scan was performed and surgeon was happy with the screw placement.Only the left l1 screw had to be re-positioned.This did not have any negative clinical effect on the patient.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 due to this issue - there were no negative clinical effects to this patient due to prolonged surgery/anesthesia (less than 10 minutes) - no other remedial actions or additional surgery are necessary, done or planned for this patient for this issue (other than repositioning of screw during this same procedure).

• 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; munich, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; munich, 81829 ; GM 81829
• Manufacturer Contact: paul neil ; olof-palme-strasse 9; munich, 81829 ; GM 81829
• MDR Report Key: 6740163
• MDR Text Key: 80947559
• Report Number: 8043933-2017-00020
• 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: Physician
• Type of Report: Initial
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2016
• 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