MAUDE Adverse Event Report: BRAINLAB AG SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 1.5); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22268-01C

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2022

Event Type  Injury  

Event Description

A spine surgery to place screws into the spinal vertebrae was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 1.5.During the procedure a screw placement was performed in another location than intended with the brainlab device involved, and there could have led to harm of the spinal cord and/or blood vessels, and thus in a worst case scenario ultimately to serious harm to the patient.The screw was replaced (repositioned) during the same surgery.To date, no harm/negative clinical effect to the patient was reported to brainlab due to this issue, nor any medical/surgical remedial actions that would have been necessary, done or planned for this patient due to this issue.Brainlab has requested further information from the customer.

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since apparently a screw placement was performed in another location than intended with the brainlab device involved, and therewith could have led to harm of the spinal cord and/or blood vessels, and thus in a worst case scenario ultimately to serious harm to the patient, although: the hospital did not report any negative clinical effects for this specific patient due to this issue nor any further remedial actions (besides replacement of the screw during the same surgery) that would have been necessary.Currently there is no indication of a systematic error or malfunction of the brainlab device, nor of insufficient measures to minimize this anticipated risk as low as reasonably practicable 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.

Manufacturer Narrative

B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since instrumentation (and potentially a screw) was placed in the patient's spine in a different position than desired with navigation involved, although according to the surgeon: the misplaced screw was detected intraoperatively with imaging, and was replaced (repositioned) successfully with navigation to the intended position during the very same surgery.(note: according to the scans provided by the hospital to brainlab, this misplaced screw was actually not replaced/re-positioned during the surgery but rather only removed).The outcome of the surgery was successful, with all screws placed in their correct final positions as intended at the end of the surgery.There was no actual harm or negative clinical effect to the patient due to the incorrect screw placement, neither due to the slight prolongation of anesthesia at this surgery, despite there was an increased risk of harm to a critical structure for a screw placed too medially (risk of damage to the medulla/spinal cord for a screw placed too medial).There were no further medical/surgical remedial actions necessary, done, or planned for this patient; hospitalization was not prolonged either.H6: 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 reported deviation of the screw path (and potentially also the screw) from the intended location at left t8 is a combination of the following factors: a temporary movement of the patient reference array due to an insufficiently rigid fixation and/or inadvertent forces applied (i.E.Use of the awl and probe) after patient registration was performed.Several reference array movements were detected by the software and were recorded in tracking data, which also indicate its occurrence during the surgery.Temporary movement of the reference array disrupts the coordinate system established during patient registration and causes a deviation between the registered pre-surgery image on which navigated instruments are tracked and the actual patient anatomy.A relative movement of the anatomy between the vertebra on which the patient reference array was attached and the vertebra being operated on, due to forces applied on the anatomy during instrumentation.Vertebra movements relative to the navigation reference array during surgery cannot be recognized or compensated by the navigation when displaying tracked instrument positions on the pre-surgery patient scan.Apparently, the resulting deviation of the registered patient image in the navigation display from the actual patient anatomy was not recognized by the surgeon with the appropriate and necessary accuracy verification during screw preparation and placement of the affected screws.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.H7: brainlab intends to reiterate the relevant topics regarding the use of the device to this customer.

Event Description

A surgery on the spine for placement of pedicle screws for correction of scoliosis at t5-l3, was performed with the aid of the display by the brainlab software spine & trauma 3d navigation 1.5.During the procedure the surgeon: with the patient in the prone position, attached the navigation reference array on the spinous process of l3 and performed an intraoperative scan with an automatic image registration of the current patient anatomy to the navigation, and verified and accepted the accuracy of the registration to proceed.Calibrated the brainlab awl and non-brainlab probe to the navigation, and verified and accepted the accuracy of the calibrations to proceed.A non-brainlab tap and screwdriver were also used during the surgery but were not calibrated or navigated for screw placement.Prepared and placed screws in the pedicles of t9-l3 (excluding right t10 and left l1), in alternating left-right order for each level.The exact surgical workflow was not provided by the surgeon, but it is likely the entry point was found using the navigated brainlab pointer, the pedicle was opened using the navigated brainlab awl, the path for the screw was prepared using the navigated non-brainlab probe and a non-navigated non-brainlab tap, and the screw was placed down the prepared path using a non-navigated non-brainlab screwdriver.At least one time during screw placement, the surgeon indicated a deviation (of an unspecified amount) between the display of the navigated non-brainlab probe when comparing its position to that of the navigated brainlab pointer, but later determined the accuracy appeared fine.Performed a second intraoperative scan with an automatic image registration of the current patient anatomy to the navigation, and verified and accepted the accuracy of the registration to proceed.The screws previously placed were determined to all have been placed correctly via this confirmation scan.Moved and attached the navigated reference array to the spinous process of t9, and performed a third intraoperative scan in the same manner as before, with a different field of view over t4-t9, and verified and accepted the accuracy of the automatic registration to proceed.Prepared and placed screws in the pedicles of t5-t8, in alternating left-right order for each level, in the same manner as before.At some point either before or during screw placement, the surgeon recalibrated the non-brainlab probe to the navigation, and verified and accepted the accuracy of the calibration to proceed.Determined at some point in the process of preparing or placing the screw at left t8, that the screw path and/or screw was placed too medially, and (if placed) the screw was removed.No image of the misplaced screw was provided by the hospital to brainlab.However, the prepared path for the screw, medial to the pedicle at left t8, was visible on the subsequent intraoperative confirmation scan.No information was provided to brainlab regarding the amount or degree by which the screw path and/or screw deviated from the intended position.Performed a final confirmation scan.There was no screw replaced (re-positioned) at left t8, but only the prepared path for this screw medial to the pedicle was visible in the scan.All other screw placements were confirmed via this scan to have been placed correctly.Completed the surgery and performed a final post-operative x-ray (with no screw at left t8 at the completion of surgery).According to the surgeon: the misplaced screw was detected with intraoperative imaging, and was replaced (repositioned) successfully with navigation to the intended position during the very same surgery.(note: according to the scans provided by the hospital to brainlab, this misplaced screw was actually not replaced/re-positioned during the surgery but rather only removed).The outcome of the surgery was successful, with all screws placed in their correct final positions as intended at the end of the surgery.There was no actual harm or negative clinical effect to the patient due to the incorrect screw placement, neither due to the slight prolongation of anesthesia at this surgery, despite there was an increased risk of harm to a critical structure for a screw placed too medially (risk of damage to the medulla/spinal cord for a screw placed too medial).There were no further medical/surgical remedial actions necessary, done, or planned for this patient; hospitalization was not prolonged either.

• Brand Name: SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 1.5)
• 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: 13535914
• MDR Text Key: 289982320
• Report Number: 8043933-2022-00009
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K183605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22268-01C
• Device Catalogue Number: 22268-01C
• Device Lot Number: SW V. 1.5.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2020
• 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