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 08/23/2018

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 in the patient's spine in a different position than desired with navigation involved, although according to the surgeon: the deviation of the k-wires were detected by the surgeon after placement with a fluoroscopic control scan before finalizing the surgery, and were replaced successfully (re-positioned successfully) with fluoroscopic guidance before placement of the corresponding pedicle screws at the very same surgery.All pedicle screws were placed correctly as intended, the final outcome of this surgery was successful as intended.There were no negative effects to the patient, neither due to the k-wire placements nor due to surgery/anesthesia delay (of ca.30min) for re-placement of the k-wires at the same surgery.There were no other remedial actions for the patient done, necessary or planned.Hospitalization was not prolonged either.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 deviating k-wires placements (by ca.5mm) is a combination of two contributing factors: 1) relative movement of the vertebra operated on (e.G.L1- s2) in relation to the vertebra (t11) the navigation reference array was fixated to, which can occur due to a non-rigid connection of the bones when applying forces to the vertebrae during the surgery.The patient anatomy also has shifted after the pre-surgery scan used for navigation, likely during the surgery, since a change in the curvature of the spine was observed at a scan performed at the end of the surgery.These bone (vertebra) movements relative to array cannot be recognized by the navigation when displaying instrument positions on the pre-surgery images.2) presumed movement of the navigation reference array on the bone during the surgery at or after draping, due to use of the patient scan drape in a way affecting the array with forces, leading to a shift between the instrument position display on the pre-surgery image dataset by the navigation and the actual patient anatomy.Apparently, the resulting deviation has not been recognized with the necessary continued verification of navigation accuracy by the user before the k-wire placements.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 minimally invasive surgery on the spine for stabilization with a posterior fusion of vertebrae l1 to s2 with placement of 7 k-wires and 7 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 t11.Performed a ct scan and verified and accepted the automatic registration of the current patient anatomy to the navigation (to the intra-operative ct scan imported into and used by the navigation).Used the navigated pointer to determine incisions and a navigated drill guide 2.4mm to drill into the pedicles, and to place the 1.8mm k-wires at these positions in the vertebrae.Performed an intra-operative confirmation fluoroscopy scan and determined that 6 of the 7 k-wires were not placed as desired: these 6 k-wires deviated by ca.5mm, below (inferior to) the intended position.The deviating 6 k-wires were re-placed under fluoroscopic guidance successfully to the intended position at the same surgery, before the corresponding screw placements.All 7 pedicle screws were placed correctly as intended following the k-wires, the final outcome of this surgery was successful as intended.According to the surgeon: the deviation of the k-wires were detected by the surgeon after placement with a fluoroscopic control scan before finalizing the surgery, and were replaced successfully (re-positioned successfully) with fluoroscopic guidance before placement of the corresponding pedicle screws at the very same surgery.All pedicle screws were placed correctly as intended, the final outcome of this surgery was successful as intended.There were no negative effects to the patient, neither due to the k-wire placements nor due to surgery/anesthesia delay (of ca.30min) for re-placement of the k-wires at the same surgery.There were no other remedial actions for the patient done, necessary or planned.Hospitalization was not prolonged either.

• 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: 7888463
• MDR Text Key: 120698922
• Report Number: 8043933-2018-00031
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481106591
• UDI-Public: 04056481106591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• 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: 71116B
• Device Lot Number: SW V. 2.6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2017
• 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