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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2019

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 was detected by the surgeon after placement with a fluoroscopic control scan before finalizing the surgery, and the k-wires 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 surgeon and previously reviewed already by the hospital, it can be concluded that the root cause for the deviating k-wire placements (approximately 6 cm or one vertebra level superior) using the aid of navigation with automatic image registration (air) for the intraoperative ct scan, is a deviation of the navigation display due to an incorrect ct gantry start position value entered by the user into the navigation system.The non-brainlab intra-operative ct scanner gantry start position was changed by the users before executing the intraoperative scan to use with the navigation system, and after the user had entered the original (other) ct gantry position information into the brainlab navigation software.Entry by the user of the correct ct gantry start position information of the ct scan into the navigation system is necessary for the automatic image registration software to correctly match the ct image dataset to the actual patient anatomy for navigation display.Apparently the resulting deviation of the navigation display due to the incorrect information entered was not recognized by the user before the placement of the k-wires with the necessary navigation accuracy verification after the automatic patient/ scan registration to the navigation 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

A minimally invasive surgery (mis) on the spine for stabilization with midline percutaneous vertebral cement augmentation of t12-l2 for an l1 fracture with placement of 4 k-wires and 4 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 operating room table.Attached the navigation reference array on t5.Performed a ct scan using an intra-operative ct scanner 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).Breathing was halted during the scan.Used a navigated drill guide to drill into the pedicles, and to place the 4 k-wires.Performed an intra-operative confirmation fluoroscopy scan and determined that all 4 k-wires were not placed as desired: placement deviated by ca.6cm superior from the intended position, in the pedicles of t11 and l1 instead of the intended t12 and l2.The deviating 4 k-wires were re-placed under fluoroscopic guidance successfully to the intended position at the same surgery, before the corresponding screw placements.All 4 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 was detected by the surgeon after placement with a fluoroscopic control scan before finalizing the surgery, and the k-wires 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: 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; 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: 8357041
• MDR Text Key: 136717484
• Report Number: 8043933-2019-00004
• 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: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• 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: 01/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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