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 09/13/2021

Event Type  Injury  

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.

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 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.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

B2, h1: a risk to the patient's health could not be excluded for these specific circumstances, since 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 with intraoperative imaging, and was replaced (repositioned) successfully with navigation to the intended position during the very same surgery.- 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 in case the screw would have been placed too medially (risk of damage to the medulla if the screw had been 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 misplaced screw at left t9 is a combination of the following factors: - a 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 and the push/pull forces applied on the surrounding skin/tissue) after patient registration was performed, especially considering the position of the reference clamp being very close to the surrounding soft tissue as displayed from the scans provided.Several reference array movements were detected by the software which also indicates its occurrence during the surgery.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

An open surgery on the spine for fixation of t3-l3 for a patient with scoliosis, with placement of pedicle screws from t2-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 positioned prone, performed the initial incision and exposure, and attached the navigation reference array on the spinous process of l2.- acquired an intra-operative scan with a non-brainlab c-arm, with automatic image registration of the current patient anatomy to the navigation, and verified and accepted the accuracy of the registration to proceed.- calibrated a brainlab awl, and a non-brainlab probe, tap, and screwdriver to the navigation, and verified and accepted the accuracy of the calibrations to proceed.- placed screws in the left pedicles of t9-t11, l1, and l2 using the following surgical workflow: determining the entry point for the screw with the navigated pointer, opening the pedicle with the navigated awl, preparing the screw path in the pedicle with the navigated tap, and placing the screw down the path with the navigated screwdriver.- moved the reference array to the spinous process of l3 and performed another intra-operative scan with automatic image registration, and verified and accepted the accuracy of the registration to proceed.- determined the left t9 screw was misplaced too laterally and removed it.(note: the surgeon initially reported the screw was placed too medially, but based on the intraoperative scan data, the screw placement was lateral to the pedicle.) the amount/degree to which the screw was misplaced was not provided by the surgeon.- used the same surgical workflow to place screws in the pedicles of left t8 and right t9.- moved the reference array to the spinous process of t9 and performed another intra-operative scan with automatic image registration, and verified and accepted the accuracy of the registration to proceed.- used the same surgical workflow to place screws in the pedicles of left t2-t4, t6, and t7, and right t2, t4, t5, t7, t8, and t10.- performed another intra-operative scan with automatic image registration, and verified and accepted the accuracy of the registration to proceed.- used the same surgical workflow to place screws in the pedicles of right t12-l3.- performed a final verification intra-operative scan and confirmed all screws were placed correctly.- completed the surgery.Note: the above specific order of screw placements was determined by brainlab using the intraoperative scans provided by the hospital.The surgeon reported the screw that was removed at left t9 was also repositioned successfully to its intended position using navigation, however the replacement was not visible on the scans provided by the hospital.Not all vertebrae were visible on every scan, so it is possible that other screw placements were performed but the resulting placements were simply not visible on the scans which were provided to brainlab.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.- 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 in case the screw would have been placed too medial (risk of damage to the medulla if the screw had been 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: 13535672
• MDR Text Key: 289517529
• Report Number: 8043933-2022-00008
• 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