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 01/22/2018

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, although according to the surgeon: the surgeon decided to remove the k-wires without correction at this surgery, and with no screw placements performed to re-schedule the surgery for the next day.The revision surgery was performed on (b)(6) 2018 (under fluoroscopy) successfully, with k-wire and screw placements correct as intended and outcome as expected.All screw positions were correct as intended after successful revision surgery.There were no negative effects on the patient, neither due to k-wire placements nor additional surgery/anesthesia (of ca.4h).The patient is doing well.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 is the (non-brainlab) k-wire diameter of 1.4 mm used in combination with the 2.5 mm navigated calibrated (non-brainlab) drill guide.Only the drill guide is navigated, a k-wire diameter ca.1 mm thinner than the inner diameter of the drill guide can cause the k-wire to deviate from the navigated position/ direction when exiting the guide, due to this mismatch.Further contributing factor: the drill guide was most probably not placed flat in the icm inset during calibration by the user, and slightly angled.The resulting deviation of the axis in the navigation display was apparently not recognized by the user with the necessary verification of accuracy after the calibration and also continuously throughout the surgery.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 fusion of t11-l3 (8 k-wires and pedicle screws intended), was performed with the aid of the display by the brainlab navigation software spine and 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 t12.Verified and accepted the automatic registration of the current patient anatomy to the navigation (to the intra-operative 3d c-arm scan imported into and used by the navigation).Breathing was halted during the scan.Calibrated a (non-brainlab) drill guide to the navigation.Placed the k-wires percutaneously on t11 and t12.Attached the navigation reference array on l4, performed another intra-operative 3d c-arm scan imported into and used by the navigation for the lumbar spine k-wire placements, verified and accepted the automatic registration of the current patient anatomy to the navigation.Breathing was halted during scan.Again calibrated the (non-brainlab) drill guide to the navigation.Placed the k-wires percutaneously on l2 and l3.After the k-wire placements, another intra-operative 3d c-arm scan was performed.The surgeon determined that the 8 k-wires were placed not as intended, all were slightly shifted in feet direction.The k-wires on the left were also slightly medial, the ones on the right shifted also slightly lateral.The surgeon decided to remove the k-wires without correction at this surgery, and with no screw placements performed to re-schedule the surgery for the next day.The revision surgery was performed on (b)(6) 2018 (under fluoroscopy) successfully, with k-wire and screw placements correct as intended and outcome as expected.According to the surgeon: all screw positions were correct as intended after successful revision surgery.There were no negative effects on the patient, neither due to k-wire placements nor additional surgery/anesthesia (of ca.4h).The patient is doing well.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; münchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer Contact: markus hofmann ; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• MDR Report Key: 7281101
• MDR Text Key: 100539010
• Report Number: 8043933-2018-00003
• 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: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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