MAUDE Adverse Event Report: BRAINLAB AG NAVIGATION SOFTWARE SPINE & TRAUMA 3D (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); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2018

Event Type  malfunction  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a pedicle screw was placed in the patient's spine in a different position than desired with navigation involved, although according to the hospital: the deviation of the pedicle screw was detected by the surgeon after placement with a fluoroscopic control scan before finalizing the surgery, and was replaced successfully with fluoroscopic guidance at the same surgery, for successful outcome of the surgery.There is no negative clinical effect to the patient due to this issue, nor due to surgery/anesthesia delay, reported by the hospital.There were no other remedial actions for the patient (other than screw correction at same surgery) that would have been done or necessary or planned, nor any prolong of hospitalization, reported by the hospital.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the main cause for one of the pedicle screw placements deviating by ca.5 mm is a movement of the navigation reference array, as also seen in the log files from the navigation for this surgery, due to an insufficiently rigid fixation on the bone, leading to a shift between the instrument position display on the image dataset by the navigation and the actual patient anatomy.Apparently, this has not been recognized with the necessary continued verification of navigation accuracy by the user before the pedicle screw placement.A further factor that might have contributed, is the relative movement of the vertebra operated on (l5) in relation to the vertebra (l4) the navigation reference array was fixated to, which can occur due to a non-rigid connection of the bones when applying forces during the surgery.This possible bone (vertebra) movement relative to array when applying forces to the vertebra at the surgery cannot be recognized by the navigation when displaying instrument positions on the pre-surgery images.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 the spine for a stabilization of vertebrae l3-s1 for spondylolisthesis with placement of 8 k-wires and 8 pedicle screws, 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.Attached the navigation reference array on l4.Performed an intra-operative c-arm scan, verified and accepted the automatic registration of the current patient anatomy to the navigation (to the intra-op c-arm scan imported into and used by the navigation).Used a navigated drill guide 3.2 mm to determine and plan the trajectories for the screws, and to place the k-wires at these positions in the vertebrae.Calibrated a (non-brainlab) tap to the navigation, and tapped the pedicle holes for the screws.Placed the pedicle screws following the navigated tapping of the pedicle holes with a non-navigated screwdriver.Performed an intra-operative confirmation fluoroscopy scan and determined that the left l5 pedicle screw was not placed as desired: this screw deviated by ca.5 mm from the intended position and was placed into the intervertebral disc.The deviating left l5 pedicle screw was re-placed under fluoroscopic guidance successfully to the intended position at the same surgery.According to the hospital: the deviation of the pedicle screw was detected by the surgeon after placement with a fluoroscopic control scan before finalizing the surgery, and was replaced successfully with fluoroscopic guidance at the same surgery, for successful outcome of the surgery.There is no negative clinical effect to the patient due to this issue, nor due to surgery/anesthesia delay, reported by the hospital.There were no other remedial actions for the patient (other than screw correction at same surgery) that would have been done or necessary or planned, nor any prolong of hospitalization, reported by the hospital.

• Brand Name: NAVIGATION SOFTWARE SPINE & TRAUMA 3D (VERSION 2.6)
• 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: markus hofmann ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 7863631
• MDR Text Key: 120396901
• Report Number: 8043933-2018-00029
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481106591
• UDI-Public: 04056481106591
• Combination Product (y/n): N
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• 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
• Device Lot Number: SW V. 2.6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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