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); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

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 4 of the 8 pedicle screws was detected by the surgeon with a post-placement intra-operative fluoroscopic c-arm verification scan before finalizing the surgery, and the screws were replaced (re-positioned) successfully with fluoroscopic guidance at the very same surgery.All pedicle screws were placed correctly as intended after correction, the final outcome of this surgery was successful as intended.There was no harm or negative effect to the patient due to the deviating screw placements, neither due to prolong of surgery/anesthesia (of ca.45min).There were further no remedial actions necessary, done or planned for this patient.Hospitalization was not prolonged either.Remedial action initiated: a comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a follow-up report to the fda upon completion of investigation.

Event Description

An open surgery on the spine for fusion of vertebrae l2-l5, with intended placement of 8 k-wires and 8 following pedicle screws, was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 2.6.A pre-surgery ct scan to use with navigation was acquired a day before this surgery.During the procedure the surgeon: positioned the patient in prone position on the operating room table.Attached the navigation reference array on vertebra l2.Performed the initial patient registration on the pre-op ct acquiring registration points on the vertebrae, to match the display of the navigation to the current patient anatomy.Verified the accuracy of the patient registration in the navigation and accepted the registration to proceed.Calibrated a non-brainlab awl to the navigation, and placed 4 k-wires into left and right l2 and l3 with the aid of the navigated awl.The 4 pedicle screws in l2 and l3 were placed with a non-navigated non-brainlab screwdriver, following the k-wires.Attached the navigation reference array on vertebra l4.Performed another patient registration on the pre-op ct acquiring registration points on the vertebrae, to match the display of the navigation to the current patient anatomy, and accepted the registration to proceed.Placed 4 k-wires into left and right l4 and l5 with again the aid of the non-brainlab navigated awl calibrated to the navigation, and placed the 4 pedicle screws in l4 and l5 again following the k-wires with the non-navigated non-brainlab screwdriver.Acquired a post-placement intra-operative fluoroscopic c-arm verification scan, and determined from the scan that the 4 pedicle screws placed in l4 and l5 deviated from the desired and intended positions, with an unintended angulation on the sagittal plane.The 4 other pedicle screws in l2 and l3 were placed as intended.Re-placed (re-positioned) the deviating 4 pedicle screws in l4 and l5 to the correct position under fluoroscopic guidance without navigation.Completed the surgery successfully as intended.According to the surgeon: the deviation of 4 of the 8 pedicle screws was detected by the surgeon with a post-placement intra-operative fluoroscopic c-arm verification scan before finalizing the surgery, and the screws were replaced (re-positioned) successfully with fluoroscopic guidance at the very same surgery.All pedicle screws were placed correctly as intended after correction, the final outcome of this surgery was successful as intended.There was no harm or negative effect to the patient due to the deviating screw placements, neither due to prolong of surgery/anesthesia (of ca.45min).There were further no remedial actions necessary, done or planned for this patient.Hospitalization was not prolonged either.

Manufacturer Narrative

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 differently angulated than expected screw placement at levels l4 and l5, can be attributed to the combination of the following factors: 1) a less than ideal point acquisition by the user during the patient region match registration at level l5, with reference array at level l4.Brainlab recommends to only acquire points on the bone to which the reference array is attached (vertebra l4 in this case).This may have caused the brainlab spine &trauma navigation software to not find a match to the actual patient anatomy (i.E.L4) 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.2) a possible relative movement of the vertebra operated on (i.E.L5) in relation where the reference array was attached (l4), when applying forces to open the pedicle with the navigated non-brainlab awl, leading to a shift between the navigation display of the image dataset and the actual patient anatomy.This relative movement occurs due to a non-rigid connection of the bones when applying forces during the surgery.These vertebra movements relative to the navigation reference array during e.G.Hardware placement, cannot be recognized by the navigation system when displaying tracked instrument positions on the pre-surgery (registration) image.Further potential contributing factor for the deviation of the screw placements: the screws may not have exactly followed the path in the bone formerly created with the navigated non-brainlab awl, when placing the screws with the non-navigated non-brainlab screwdriver.Since the non-brainlab screwdriver and the screw were not navigated, this factor is independent of the use of navigation, i.E.The navigation did not contribute to this possible cause.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

Correction to the initial report: as per the data and log files provided to brainlab, only one patient registration on the pre-op ct acquiring registration points on the vertebrae l5 was used for this surgery, to match the display of the navigation to the current patient anatomy.Therefore also the navigation reference array was only attached at l4, without swap of the array from a different vertebra.

• 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
• MDR Report Key: 8619438
• MDR Text Key: 145500001
• Report Number: 8043933-2019-00023
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481106591
• UDI-Public: 04056481106591
• Combination Product (y/n): N
• PMA/PMN Number: K070106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/17/2019
• Supplement Dates Manufacturer Received: 04/18/2019
• Supplement Dates FDA Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other