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 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since screws were 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.- there was no reported prolonged anesthesia - no other remedial actions are necessary, done or planned for this patient.Surgery plan changed mid-operation and surgeon stated contentment with brainlab navigation and final result.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 2 screws on the right side placed differently than intended is that the screwdriver may have been pushed by bone as the surgeon indicated at the first attempt.The surgeon may have only initially confirmed the correct position of the screwdriver using navigation.Further, the screws mounted to the screwdriver may not have been mounted rigid or may have become loose during the approach to the bone.Further contributing factors are: - the custom made interface of the nuvasive screwdriver for the brainlab starlink adapter was used in this case but has not been tested and validated by brainlab - third party marker spheres were used in this case which are not tested and validated by brainlab.There is no indication of a systematic error or malfunction of the brainlab 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.

Event Description

Four (4) pedicle screws were planned to be placed.Two (2) screws on the left side were placed correctly, but 2 screws placed on the right side had to be explanted due to them not being within the vertebral body, but rather placed too high.The procedure performed was a "1 level m.I.S.Plif of l2/3" (i.E.Minimally invasive posterior lumbar interbody fusion).The brainlab spine and trauma 3d 2.6 application in combination with the siemens arcadis orbic 3d for automatic image registration was used.A laminectomy was not performed.Navigated instruments were brainlab awl, brainlab probe, nuvasive tap and nuvasive screwdriver.No k-wires were placed.Workflow: - l2 left was placed.- attempted l2 right but assistant had difficulty with screw placement.The assistant placing the l2 right screw had difficulties only at the screw placement stage.He was able to awl, probe and tap successfully but found it challenging to keep the screw on the correct trajectory.The lead surgeon then stopped the assistant attempting to place the l2 right screw; went back to the left (surgeon's) side.The assistant said that "it felt like the he was being pushed by the bone".- l3 left was placed.At this stage both left screws were now placed.No right side screws placed.- l2 right side attempted again with difficulty coming at the screw stage.The surgeon switched to a smaller tap and smaller straight probe after the first try.L2 right was placed.- l3 right side was placed; with difficulty.Result: l2 and l3 on the right side were both placed too high in a/p coronal plane.L2 was approximately 7 mm too high and l3 was 9 mm too high.Left side was accurate.Screws at l2 and l3 on the right side were both removed (explanted) and not replaced.The procedure was completed as uni-lateral fusion.However, 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 no reported prolonged anesthesia.- no other remedial actions are necessary, done or planned for this patient.Surgery plan changed mid-operation and surgeon stated contentment with brainlab navigation and final result.

• 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 ; 89 9915680
• MDR Report Key: 6618325
• MDR Text Key: 76959103
• Report Number: 8043933-2017-00014
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481106591
• UDI-Public: 04056481106591
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 22268A
• Device Catalogue Number: 22268A
• Device Lot Number: SW V. 2.6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2016
• 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