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 03/26/2019

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a pedicle screw was placed in the patient's spine in a different position than desired with navigation involved, although according to the hospital: all screw placements were acceptable (incl.The screw in right l5), and the final outcome of this surgery was successful as intended.There were no negative clinical effects to the patient (also not due to some unwanted bone removed from l5, and surgery/anesthesia delay of about 20 minutes).There were no remedial actions necessary, done or planned for this patient, nor was hospitalization prolonged.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 placed at right l5 from the intended/planned position is: the pre-operative ct scan used for manual registration did not completely fulfill the requirements of the brainlab ct scan protocol and the 3d reconstruction setting in the navigation software (bone threshold) was less than ideal, causing the navigation software to not find a match of the pre-operative ct scan to the actual/ current patient anatomy that was as accurate as desired for this specific patient/ surgery.This lead to a rotated region match, which apparently was not detected during verification.Further contributing factor, to a lesser extent: the scan was more than one month old and may have featured an older patient anatomy that was different than the anatomy during the case.Apparently the resulting deviation of the navigation display was not recognized by the user (prior to screw placement) with the necessary navigation accuracy verification of the registration.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 (b)(6) 2019) on the spine for plif (posterior lumbar interbody fusion) with intended placement of 4 pedicle screws in l4/l5, was performed with the aid of the brainlab navigation software spine&trauma 3d 2.0.A pre-operative ct scan was acquired more than 1 month before the 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 l5.Performed the initial patient registration on the pre-operative ct scan (manual registration using region matching at l4) to match the display of the navigation to the current patient anatomy.Verified the accuracy of the registration and determined it to be good.Planned trajectories and created screw canals using aid of navigation (pre-calibrated brainlab pointer, pre-calibrated brainlab drill guide).Inserted screws in right and left l4 (without aid of navigation).Performed patient registration on the pre-operative ct scan (manual registration using region matching at l5) to match the display of the navigation to the current patient anatomy.Verified the accuracy of the registration and determined it to be good.Planned trajectories and created screw canals using aid of navigation (pre-calibrated brainlab pointer, pre-calibrated brainlab drill guide).Inserted screw in right l5 (without aid of navigation).Moved to left l5 and detected that the navigation instrument position display deviated from the actual position on the patient anatomy.Attempted a new registration twice, but could not achieve an acceptable accuracy as desired for this specific workflow step.Decided to abandon aid of navigation and placed the left l5 screw with aid of a c-arm.Verified the position of all 4 screws with the c-arm and realized that screw in right l5 was placed slightly inferior (the exact amount of deviation is unknown), but considered its position still acceptable.According to the hospital: all screw placements were acceptable (incl.The screw in right l5), and the final outcome of this surgery was successful as intended.There were no negative clinical effects to the patient (also not due to some unwanted bone removed from l5, and surgery/anesthesia delay of about 20 minutes).There were no remedial actions necessary, done or planned for this patient, nor was hospitalization prolonged.

• 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: 8548934
• MDR Text Key: 143260741
• Report Number: 8043933-2019-00015
• 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: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• 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: 03/26/2019
• 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