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.

• 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: markus hofmann ; 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
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K070106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 05/17/2019 Patient Sequence Number: 1