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 Problem Use of Device Problem (1670)

Patient Problems Nerve Damage (1979); Paresis (1998); Tactile Disorders (4419)

Event Date 11/10/2021

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 were negative clinical effects for the patient, according to the surgeon: the misplaced screws caused harm to the nerves at l4 and l5 on the right side, which resulted in a paresis (weakness) of l5 on the patient's right side, assessed by the surgeon as 2-3 on a scale of 5, causing the patient problems to lift the leg on one side; additionally the harm to the nerves resulted in dysesthesia (abnormal sensations) of l4 and l5 on the patient's right side.Per the surgeon, the harm is considered permanent thus far (he specified the paresis is improving but is still present).Hospitalization was prolonged by 21 days.Despite the deviations of the four screws were detected by the surgeon after placement with fluoroscopic control scans before finalizing the surgery, and the screws were replaced (re-positioned) successfully to their intended positions using navigation at the same surgery.Despite there was no other harm or negative effect to the patient reported, neither due to the prolonged anesthesia of 4 hours, and there were no further medical/surgical remedial actions necessary, done or planned.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause of the inaccurate screw placement of left l4, right l4, right l5, and left l5 deviating ca 8 mm caudally from their intended positions was most likely a movement of the patient reference array due to an insufficient rigid fixation, and/or inadvertently applied forces to the array unit during the procedure, after the patient was registered to navigation, especially considering the direct contact of the reference clamp with the surrounding soft tissue as displayed from the scans provided.The array movement software warning also appeared during the surgery, further indicating the occurrence of reference shift during this placement.Movement of the reference array after registration is performed disrupts the coordinate system established during registration and results in an inaccurate display of tracked instruments on the registered data set in the navigation software compared to their actual positions on the patient anatomy.An additional factor that may have contributed to the reported inaccuracy was a relative movement of the vertebrae (l4 and l5) in relation to l3 where the reference was attached during the surgery.The significant amount of forces applied with the navigated screwdriver increases the likelihood of a relative bone movement.Vertebrae movements relative to the navigation reference array during surgery cannot be recognized by the navigation when displaying tracked instrument positions.Apparently, the resulting deviation in the navigation display between the registered preoperative image and the actual patient was not recognized by the user with the appropriate and necessary accuracy verification during the procedure while preparing the screw path and placing the screws at left and right l4 and l5.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 reiterate the relevant topics regarding the use of the device to this customer.

Event Description

An open surgery on the lumbar spine with intended placement of 4 pedicle screws for fixation, was performed with the aid of the display by the brainlab software spine & trauma 3d navigation 1.5.During the procedure the surgeons: with the patient in prone position, made an incision over l4-l5 and attached the navigation reference array on the spinous process of l3.Acquired a 3d fluoroscopy scan using an intra-operative 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 non-brainlab all-in-one screwdriver to the navigation, and accepted the accuracy of the calibration to proceed.Used the navigated non-brainlab all-in-one screwdriver to place screws in the left and right pedicles of l4 and l5.Performed a verification 3d fluoroscopy scan and determined that all screws were 7-10mm caudal of the intended trajectory, in the intraforaminal area.Performed a laminectomy at l4 and a foraminotomy at l4 and l5 under a microscope.Determined that the nerves at l4 and l5 on the left side and also at l5 on the right side were in contact with the screws, but were seemingly not harmed.The nerve at the right side of l4 was damaged in the nerve pocket and the fibers were on the thread of the screw, but the nerve fibers seemed not to be disrupted.Repaired and glued the defect on the dura at right l4.Removed all four screws, acquired another 3d fluoroscopy scan using an intra-operative 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 non-brainlab awl and straight probe to the navigation and accepted the accuracy of the calibration to proceed.Used the navigated awl and probe to prepare the path for the screws in the pedicles of l4 and l5, and placed screws in the prepared paths successfully to their final intended positions.Completed the surgery.According to the surgeon: the misplaced screws caused harm to the nerves at l4 and l5 on the right side, which resulted in a paresis (weakness) of l5 on the patient's right side, assessed by the surgeon as 2-3 on a scale of 5, causing the patient problems to lift the leg on one side; additionally the harm to the nerves resulted in dysesthesia (abnormal sensations) of l4 and l5 on the patient's right side.Per the surgeon, the harm is considered permanent thus far (he specified the paresis is improving but is still present).Hospitalization was prolonged by 21 days.The deviations of the four screws were detected by the surgeon after placement with fluoroscopic control scans before finalizing the surgery, and the screws were replaced (re-positioned) successfully to their intended positions using navigation at the same surgery.There was no other harm or negative effect to the patient reported, neither due to the prolonged anesthesia of 4 hours, and there were no further medical/surgical remedial actions necessary, done or planned.

• 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: 13595463
• MDR Text Key: 290780259
• Report Number: 8043933-2022-00011
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 04056481142025
• UDI-Public: 04056481142025
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 01/27/2022

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: 22268-01C
• Device Catalogue Number: 26663A
• 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: 01/27/2022
• Initial Date FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2020
• 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; Hospitalization; Required Intervention