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); Improper or Incorrect Procedure or Method (2017)

Patient Problems Paralysis (1997); Hypoesthesia (2352)

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since k-wires (that guided subsequently placed screws) were placed in the patient's spine in a different position than desired with the brainlab device involved, and a negative clinical effect to the patient (incomplete paraplegic syndrome) resulted from the undesired screw placement, despite all screws were revised in the very same surgery, and placed in their correct final positions as intended at the end of the surgery.A left sided myelomalacia (softening of the spinal cord), and a dural tear on left t6 was identified, and the patient suffered an incomplete paraplegic syndrome from the incorrect screw placement on the left side (in detail a functional plegia in the left leg and an hypoesthesia in both legs); a certain amount of deficit is expected to remain but it is not foreseeable at the time being.The surgery time was extended by 2h, leading to an increased blood loss; a prolonged hospital stay of 1-2 weeks, and subsequent rehabilitation of the patient is required due to this issue; there are no further medical/surgical remedial actions necessary, done or planned for this patient.According to the results of the brainlab technical investigation, and the information provided by the hospital, it can be concluded that the root cause of the misplaced screws bilaterally at c7-t2 and t5-t6, by approximately 10 mm in the same direction towards the patient's right side, was a movement of the patient reference array due to a non-rigid fixation, and/or inadvertent forces applied (e.G.Bumping into the array, cleaning off the reflective marker spheres, etc.).A movement of the patient reference array after registration can lead to an inaccurate display of tracked instruments on the registered data set in the navigation software compared to their actual positions on the patient anatomy that cannot be compensated for by the navigation software.Other factors that could have contributed to the deviated screw placements (to a lesser extent) include: movement of the patient anatomy relative to the patient reference array.Multi-level navigation (i.E.Operating on a different vertebra than the one the reference array is fixated to or operating across multiple vertebrae without remounting the reference array and reregistering), especially across so many vertebrae and with a spine instability (i.E.Fracture), can lead to relative movements of the vertebrae that are not recognized by the navigation software, thus resulting in navigation inaccuracies.- the use of k-wires (estimated 1.2 mm) with a diameter smaller than that of the drill guide (3.2 mm) used to create the screw paths in which the k-wires were placed.The placed k-wires could have deviated within the drilled paths, which the screws would have then followed, thus resulting in a deviated screw placement.The use of a non-navigated screwdriver to place screws into the bone.Any deviations of the screw while being advanced into the bone with the non-navigated third party screwdriver does not involve brainlab, and its navigation system, as this surgical step was not tracked in the navigation system.The use of a damaged (bent) pointer that was used for verification purposes at this procedure.The use of a damaged pointer can result in a deviated display of the instrument in navigation.(the damage occurred during use at the user facility, i.E.After handover to the user, e.G.Due to improper handling and/or long-term use.) apparently, the resulting deviation in the navigation display was not recognized by the surgeon with the necessary, and appropriate accuracy verifications after registration (i.E.At verification step) and throughout the procedure.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 re-iterate the relevant topics regarding the use of the device to this customer.

Event Description

An open surgery (on (b)(6) 2020) on the spine for stabilization, with planned k-wire/screw placements at c7, t1, t2, t5, t6 (to address an incomplete spinal cord injury due to pathological fractures at t3 and t4 with an epidural and paravertebral tumor mass), and tumor resection at t3 and t4, was performed with the aid of the display by the brainlab navigation software spine & trauma 3d 2.6.During the procedure the surgeon: positioned the patient in prone position on the or table; placed a metal x-clamp with the 4-sphere array on the spinous process of t1; acquired an airo ct scan with automatic image registration (to match the display of the navigation to the current patient anatomy), verified accuracy of the registration using the navigated pointer and accepted it.Calibrated a brainlab drill guide in the navigation software; drilled holes in the bone using the navigated drill guide, and confirmed accuracy of the holes using the navigated pointer before inserting k-wires into the drilled holes; placed screws (in t6, t5, t2, c7, t1) using a non-navigated non-brainlab screwdriver, following the placed k-wires; removed the reference clamp/array for tumor removal, which was performed using the aid of the navigated pointer (but with no reported issues/inaccuracies during this step); performed a corporectomy (removal of all or part of a vertebral body) at t3 and t4, and implanted a distraction cage at t3 and t4 without aid of navigation; replaced the reference clamp/array on the spinous process of l1 and acquired a second airo ct scan with automatic image registration; detected a deviation of all screws in the same direction towards the patient's right side, i.E.All screws on the left side were placed too medial (affecting the spinal canal and spinal cord) and all screws on the right side were placed too lateral (and passing the vertebral body); entry points of the screws were determined acceptable; removed rods and revised the screws successfully with aid of navigation using the new registration scan; a third scan confirmed acceptable corrected screw positions.According to the hospital/surgeon: the k-wires/screws placed not as intended were corrected in the very same surgery; at the end of the surgery, all screws were placed in their correct final positions as intended; however, a left sided myelomalacia (softening of the spinal cord) and a dural tear on left t6 was identified, and the patient suffered an incomplete paraplegic syndrome from the incorrect screw placement on the left side (in detail a functional plegia in the left leg and an hypoesthesia in both legs); a certain amount of deficit is expected to remain, but it is not foreseeable at the time being; the surgery time was extended by 2h, leading to an increased blood loss a prolonged hospital stay of 1-2 weeks, and subsequent rehabilitation of the patient is required due to this issue; there are no further medical/surgical remedial actions necessary, done, or planned for this patient.

• 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; münchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer Contact: andrea miller ; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• MDR Report Key: 10539675
• MDR Text Key: 214731080
• Report Number: 8043933-2020-00048
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481106591
• UDI-Public: 04056481106591
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K070106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22268A
• Device Catalogue Number: 22268A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability