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

Model Number 22268-02A

Device Problem Use of Device Problem (1670)

Patient Problem Paresis (1998)

Event Date 11/29/2022

Event Type  Injury  

Manufacturer Narrative

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, and there was a negative effect to the patient (lower extremity weakness) although according to the surgeon: - the deviation of 5 screws placed with the aid of navigation was detected by the surgeon with intra-operative ct before finalizing the surgery, and the screws were replaced (re-positioned) during the very same surgery.- the final outcome of this surgery was successful as intended, with the placements correct at the end of the surgery.- as a negative effect to the patient from the surgery, "some lower extremity weakness" was communicated.The surgeon stated the weakness is "positional" referring to how the patient was seated during rehab when they were testing quadriceps muscle.The severity of this "weakness", if it is reversible or might be permanent, also if this effect might be at all related to the deviating placements with navigation remains unknown to brainlab.- the patient underwent normal physical therapy and was sent home.- there was no harm or negative clinical effect to the patient due to the surgery/anesthesia prolongation of 10-15 minutes.- there were no further remedial actions for the patient done, necessary or planned.There was no prolongation of hospitalization reported 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 5 deviating pedicle screws at left t10, t11, t12, l1 and right l1 shifted by up to 10mm to the patient's right side is: - reference movement due to a not suitably rigid fixation by the user as required, and/or inadvertent forces applied to the reference array at the surgery.A shift of a the reference array fixation is visible in between the 1st and 2nd intraoperative ct scan.That indicates that a reference array movement did occur at this surgery due to a not suitably rigid fixation in the bone, and/or forces applied to the array unit e.G.During pulling the skin while placing screws.Apparently, the resulting deviation between the actual patient anatomy during surgery and the registered preplacement patient image scan displayed by the navigation was not recognized by the user with the necessary navigation accuracy verification throughout the procedure, during the preparation and placement of the screws at left t10, t11, t12, l1 and right l1.Further potentially contributing factors for the deviation, from the information provided of this surgery, also have been: - calibration of the non-brainlab tap: the used instrument array size m appears to be too small for the long instrument.The software displayed a warning, that the calibration result is not ideal, which was ignored by the user.Furthermore, a custom made adapter was used: the custom attachment to be integrated with a brainlab array has not been officially tested nor accepted by brainlab and therefore brainlab is not in a position to determine its accuracy, compatibility or safety of this non-brainlab instrument, neither in regard to use with brainlab navigation.- visibility of the instruments to the brainlab camera: in case navigated instruments are not clearly visible to the camera during use, deviations of the display of the instruments on the registered scan in the navigation can result.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.

Event Description

A minimally invasive surgery on the thoracic and lumbar spine for fusion of vertebrae t9-s2, as a third stage of a surgery of which the previous two stages had been completed earlier the same day without navigation, with intended placement of 22 pedicle screws and 2 implants, was performed with the aid of the display by the brainlab spine & trauma 3d navigation software 1.5.During the procedure the surgeon: with the patient in prone position, attached the navigation reference array with the 2-pin fixator to the right ilium/sacrum.Acquired an intra-operative ct of the patient's region of interest with automatic image registration of the current patient anatomy to the navigation.Verified the registration and accepted the accuracy to proceed.- starting at t10 and continuing bilaterally at each level moving in the caudal direction, used the navigated drill guide to align to the pedicle, created and saved the trajectory for the screw, and drilled into the vertebrae to create path in the pedicle.- used a navigated non-brainlab tap to prepare the paths in the pedicles, and (for some unspecified screws) updated the saved screw trajectory when the tap was in the pedicle.- placed the screws with a navigated non-brainlab screwdriver into the prepared paths.- at a certain unspecified time, experienced a problem with the navigated tap that was not being consistently tracked in navigation.The tap was re-calibrated to the navigation which solved the tracking issue.- detected a deviation of the display of the navigated screwdriver compared to its actual position on the anatomy while placing a screw at l2, which was not aligning to the previous placement of the navigated drill and tap.The reflective marker spheres of the navigation array on the screwdriver were replaced, the screwdriver was disassembled and reassembled, and the navigation reference array was swapped to another, after all of which the problem was resolved.- used k-wires to aid in placement of the l2 screws instead of navigation.- continued to use the navigated screw placement workflow starting at l3, moving bilaterally in the caudal direction placing screws in the pedicles, and completed the rest of the screw and implant placements.- acquired a verification intra-operative ct, and determined that 5 screws were misplaced (left t10, t11, t12, l1 and right l1), in the medial direction (amount of deviation not specified).- removed and replaced all 5 screws using the navigated screwdriver.- completed the surgery successfully as intended.According to the surgeon: - the deviation of 5 screws placed with the aid of navigation was detected by the surgeon with intra-operative ct before finalizing the surgery, and the screws were replaced (re-positioned) during the very same surgery.- the final outcome of this surgery was successful as intended, with the placements correct at the end of the surgery.- as a negative effect to the patient from the surgery, "some lower extremity weakness" was communicated.The surgeon stated the weakness is "positional" referring to how the patient was seated during rehab when they were testing quadriceps muscle.The severity of this "weakness", if it is reversible or might be permanent, also if this effect might be at all related to the deviating placements with navigation remains unknown to brainlab.- the patient underwent normal physical therapy and was sent home.- there was no harm or negative clinical effect to the patient due to the surgery/anesthesia prolongation of 10-15 minutes.- there were no further remedial actions for the patient done, necessary or planned.There was no prolongation of hospitalization reported 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 pascarella ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 16024030
• MDR Text Key: 305920091
• Report Number: 8043933-2022-00067
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2022

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: 22268-02A
• Device Catalogue Number: 22268-02A
• Device Lot Number: SW V. 1.5.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/21/2022
• 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): Disability; Other