MAUDE Adverse Event Report: BRAINLAB AG SPINE & TRAUMA 3D NAVIGATION SOFTWARE (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)

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

Event Date 03/22/2019

Event Type  Injury  

Manufacturer Narrative

Outcomes to adverse event, type of reportable event: a risk to the patient's health could not be excluded for these specific circumstances, since screws were placed in the patient's spine in a different position than desired with navigation involved, although according to the surgeon: the deviation of the 2 screws was detected by the surgeon after placement with a fluoroscopic control scan before finalizing the surgery, and the screws were replaced successfully (re-positioned successfully) with conventional methods, without the aid of navigation, at the same surgery.All pedicle screws were placed correctly as intended, the final outcome of the surgery was successful as intended.There were no negative effects to the patient, neither due to screw placements nor due to surgery/anesthesia delay (of ca.5min) for re-placement of the screws at the same surgery.There was no (direct or increased) risk to harm a critical structure (e.G.Spinal cord and/or connected nerves or blood vessels) due to the deviating screw placements at this surgery.There were no other remedial actions for the patient done, necessary or planned.Hospitalization was not prolonged either.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the deviation of screw placements by approximately 5 mm at level l5 is: a less than ideal point acquisition by the user during the patient region match registration at level l5, and a less than ideal ct scan used for the patient registration for navigation that did not fulfill all the requirements of the brainlab ct scan protocol (the reconstruction setting in the ct scan did not match the required soft tissue kernel/ windowing).In combination, these caused the brainlab spine &trauma navigation software to not find a match to the actual patient anatomy that was as accurate as desired for this specific patient/ surgery.Apparently the non-ideal match was not detected during the necessary verification of navigation accuracy by the user before the screw placements.Further potential contributing factors are: possible movement of the navigation reference in relation to the vertebra it was attached on i.E.S1, since stability of the reference clamp may have not been ideal due to the patient's vertebra anatomy (very small spinous process at s1).Movement of the navigation reference array relative to bone anatomy during e.G.Hardware placement, cannot be recognized by the navigation system when displaying tracked instrument positions (e.G.Pointer or drill guide or screwdriver) on the pre-surgery (registration) image.The non-brainlab screwdriver with inserted screw did not fit appropriately in the calibration receptacle of the brainlab instrument calibration matrix, which may have led to a less than ideal calibration of the instrument axis.The misplaced instrument axis may not have been recognized by the user with the necessary verification of navigation accuracy after the calibration and also continuously throughout the surgery.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.Remedial action taken: brainlab intends to reiterate the relevant topics regarding the use of the device to this customer.

Event Description

An open surgery on the spine for a stabilization of l4-l5 for spondylolisthesis with planned placement of 4 pedicle screws, was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 2.6.A pre-operative ct scan was performed on the same day as the surgery, to use with navigation.During the procedure the surgeon: positioned the patient in a prone position on the or table.Attached the navigation reference array on s1.Performed the initial patient registration on the pre-op ct acquiring registration points on vertebra l5 to match the display of the navigation to the current patient anatomy.Verified the accuracy of the registration on l5 and l4, and accepted the registration to proceed.Used the brainlab pointer to plan the 2 screw positions for l5 with navigation using the virtual screw function.Calibrated a non-brainlab drill guide to the navigation, aligned the drill guide to the planned screw positions using the aid of navigation, and drilled into the pedicles of l5.Calibrated a non-brainlab screwdriver to the navigation, aligned the screwdriver to the planned screw positions using the aid of navigation, and placed the pedicle screws in l5.Performed an intra-operative fluoroscopy (x-ray) verification scan and determined the l5 screws were not placed as desired: the entry points of both screws were at the intended position but the screws within the bone anatomy deviated by ca 5mm from the intended position.Replaced (re-positioned) the deviating l5 screws using conventional methods without the aid of navigation.Continued the surgery and placed the l4 pedicle screws using conventional methods, without the aid of navigation, and completed the surgery successfully as intended.According to the surgeon: the deviation of the 2 screws was detected by the surgeon after placement with a fluoroscopic control scan before finalizing the surgery, and the screws were replaced successfully (re-positioned successfully) with conventional methods, without the aid of navigation, at the same surgery.All pedicle screws were placed correctly as intended, the final outcome of the surgery was successful as intended.There were no negative effects to the patient, neither due to screw placements nor due to surgery/anesthesia delay (of ca.5min) for re-placement of the screws at the same surgery.There was no (direct or increased) risk to harm a critical structure (e.G.Spinal cord and/or connected nerves or blood vessels) due to the deviating screw placements at this surgery.There were no other remedial actions for the patient done, necessary or planned.Hospitalization was not prolonged either.

• Brand Name: SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 2.6)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• Manufacturer Contact: maura boyle ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 8519472
• MDR Text Key: 142272150
• Report Number: 8043933-2019-00013
• 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: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 03/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2019
• 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