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 06/23/2018

Event Type  malfunction  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since k-wires were placed minimally invasive in the patient's spine in a different position than desired with navigation involved, leading to a perforation of the dura in the spinal canal and a temporary csf leak, although according to the surgeon: - the surgeon realized at the surgery that the 2 k-wires were placed other than intended, confirmed with intra-op imaging after placements.- the position of the deviating k-wires was corrected at the very same surgery, before pedicle screw placements.- after the replacement of the k-wires, the csf leak stopped.The perforation did not need to be repaired, because it healed by itself.- since the spinal canal was not perforated completely, the risk for the patient is considered low due to this issue.- the outcome of the surgery was successful as intended, with all screw positions correct as intended.- there were no negative effects to the patient, neither due to k-wire placements nor the perforation, nor due to surgery/anesthesia prolong (of ca.45min to correct k-wire positions).- there were no other remedial actions necessary, done or planned for this patient.- hospitalization was not prolonged either for this patient.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the main cause for the deviation of the k-wires is: - relative movements of the vertebra operated on (e.G.T11), in relation to the vertebra (l5) the navigation reference array was fixated to, can occur due to the non-rigid connection of the bones when applying forces during the surgery.The vertebrae in between of this patient had fractures, and osteoporosis was present also.These bone movements relative to the navigation reference cannot be recognized by the navigation, the navigation reference must be fixated with a rigid connection to the bone operated on.Apparently, this has not been recognized with the necessary continued verification of navigation accuracy by the user before or at the k-wire placements.A further factor that might have contributed, is that the non-brainlab 3d c-arm used for the automatic registration of the scan imported into the navigation was damaged, and also had sporadic drive movement issues.This might have led to added deviations for the automatic registration of the scan to the navigation, despite the registration accuracy was verified to be acceptable by the surgeon for this scan before use.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

A minimally invasive surgery on the spine for a stabilization of vertebrae t11-l4 for vertebrae fractures, was performed with the aid of the display by the brainlab navigation sw spine&trauma 3d 2.6.Intended were 8 k-wires and 8 pedicle screws following the k-wires, each 2 left and right in t11, t12, l3 and l4.During the procedure the surgeon: - positioned the patient in prone position on the operating room table.- attached the navigation reference array on l5.- performed an intra-operative 3d c-arm scan (breathing was halted during the scan).- verified and accepted the automatic image registration of this scan imported into and used by the navigation in relation to the current patient anatomy.- calibrated an instrument to the navigation (needle) to guide for the pedicle opening/drilling.- placed k-wires, and performed an intra-op c-arm control imaging after placements.- determined from the control imaging that 2 k-wires in the vertebra t11, left and right, were placed not as intended and deviated by ca.5mm to the left direction.The k-wire displacement had led to a perforation of the dura in the spinal canal, and a temporary csf leak.The positions of the deviating k-wires were corrected at the very same surgery.After the replacement of the k-wires, the csf leak stopped.The pedicle screws were placed as originally planned without using navigation, just following the k-wires.All pedicle screws were placed correctly as desired, the surgery was completed successfully with the intended outcome.According to the surgeon: - the position of the deviating k-wires was corrected at the very same surgery, before pedicle screw placements.- after the replacement of the k-wires, the csf leak stopped.The perforation did not need to be repaired, because it healed by itself.- since the spinal canal was not perforated completely, the risk for the patient is considered low due to this issue.- the outcome of the surgery was successful as intended, with all screw positions correct as intended.- there were no negative effects to the patient, neither due to k-wire placements nor the perforation, nor due to surgery/anesthesia prolong (of ca.45min to correct k-wire positions).- there were no other remedial actions necessary, done or planned for this patient.Hospitalization was not prolonged either for this patient.

• 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: 7713311
• MDR Text Key: 114814505
• Report Number: 8043933-2018-00021
• 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: Physician
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• 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: 71116A
• Device Lot Number: SW V. 2.6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2016
• 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