MAUDE Adverse Event Report: BRAINLAB AG SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 2.0); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22260

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since pedicle screws were placed in the patient's spine in a different position than desired with navigation involved, although according to the hospital: the final screw placements were correct as intended (with 2 screws replaced successfully at the same surgery), and the final outcome of this surgery was successful as intended.There were no negative clinical effects to this patient (also not due to surgery/anesthesia delay of about 25 minutes).There were no further remedial actions reported that would have been necessary, done, or planned for this patient, nor was a prolongation of hospitalization reported.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the main root cause for the deviation of the screw positions in c7 from the intended screw positions (both pedicle screws had a similar angular deviation) is a movement of the navigation reference array during the surgery in relation to the vertebra it was attached on i.E.C7, likely due to unintended contact with the retractor mounted very close and due to expected forces on patient anatomy applied during surgery, and/ or due to insufficient fixation (not all teeth in bone, and mounted high on top end of spinous process), leading to a shift between the navigation display of the image dataset and the actual patient anatomy.The movement likely occurred after planning of the entry point (since the entry point is correct).Movement of the navigation reference array relative to bone anatomy cannot be recognized by the navigation system when displaying tracked instrument positions (e.G.Pointer) on the pre-surgery (registration) image.Additionally, the method used by the surgeon (navigating the pointer only, marking the trajectory/ angle on the drape, then placing screws with non-navigated drill and non-navigated screwdriver) might have contributed to the issue.For clarity, navigation did not contribute to potential deviations introduced by these manual surgery steps.Apparently the resulting deviation of the navigation display was not recognized by the user (prior to screw placements) with the necessary navigation accuracy verification of the registration throughout the procedure.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

An open surgery on the spine for c6-c7 fusion was performed with the aid of the brainlab navigation software spine & trauma 3d 2.0 (on (b)(6) 2019).The surgery was initially posted as c3-c7 fusion, but was changed to a c6-c7 fusion (reason for change is unknown).A pre-operative ct scan was acquired 3 days prior surgery (on (b)(6) 2019), to use with navigation.During the procedure the surgeon: positioned the patient in prone position on the or table.Attached the spine reference x-clamp (with 3 sphere reference array) to c7 (in close proximity to a retractor).Performed the initial patient registration on the pre-operative ct scan (manual registration using region matching at c7) to match the display of the navigation to the current patient anatomy.Verified the accuracy of the registration and determined it as good.Planned the entry points in c7 using aid of navigation (brainlab pointer) and marked the entry points using a non-navigated drill.Planned the trajectories in c7 using aid of navigation (brainlab pointer) and transferred the angle at which the pointer was held manually to the drape on the skin using a sterile pen.Inserted the screws in pedicles of c7 without aid of navigation (using a non-navigated drill and non-navigated screwdriver).Obtained a fluoro image (c-arm) to verify screw positions and recognized a deviation of screw paths and target points (more inferior than panned) (the entry points were correct).Decided to remove the screws, adjusted the retractor, and re-clamped the reference array.Performed a new patient registration on the pre-operative ct scan (manual registration using region matching at c7).Verified the accuracy of the registration and determined it as good.Placed screws in pedicles of c7 and subsequently in pedicles of c6 (using the method described above).Verified screw positions with fluoro image (c-arm) and neuromonitoring and determined that all screws were placed as intended.According to the hospital/surgeons: the final screw placements were correct as intended (with 2 screws replaced successfully at the same surgery), and the final outcome of this surgery was successful as intended.There were no negative clinical effects to this patient (also not due to surgery/anesthesia delay of about 25 minutes).There were no further remedial actions reported that would have been necessary, done, or planned for this patient, nor was a prolongation of hospitalization reported.

• Brand Name: SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 2.0)
• 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: 8590384
• MDR Text Key: 144411619
• Report Number: 8043933-2019-00020
• 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: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22260
• Device Catalogue Number: 22260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2013
• 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