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 03/08/2017

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 minimally invasive in the patient's spine in a different position than desired with the brainlab device involved, although according to the hospital: - the unintended position of the right side l5 screw was detected with post-op ct scan (b)(6) 2017.The other screw positions were correct as intended.- the revision surgery was on (b)(6) 2017 (conventional with fluoro).The one l5 screw was revised.- all screw positions were correct as intended after successful revision surgery.- there were no further negative effects on the patient, other than leg pain after original surgery resolved with (successful) revision surgery, neither due to screw placements nor additional surgery/anesthesia (of 1 hr 14 min).The patient did not need to return to surgery, and has needed no other surgical interventions.- there were no other remedial actions necessary, done or planned for this patient (other than screw correction done at revision surgery).- the patient arrived at the hospital the day of the revision surgery and was discharged the same day.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the undesirable screw position is a relative movement of the vertebra l5 during the surgery in relation to the navigation reference array fixated to the iliac crest.The placement of a cage with removal of the spinal disc, and the laminectomy performed additionally reduced rigidity between l5 and the iliac crest.Since the screwdriver was not navigated, brainlab cannot determine if the k-wire was originally placed at the intended location for the non-navigated screw to follow.Apparently, this has not been recognized with the necessary continued verification of navigation accuracy by the user.Further contributing factor: according to the surgeon, due to the non-ideal image quality for this specific patient/surgery provided by the non-brainlab 3d c-arm to the navigation system, it was difficult to orientate.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 lumbar spine for a fusion of l5-s1 (4 pedicle screws, 2 per level) with a cage placement between l5 and s1, was performed with the aid of the virtual 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 operating room (or) table.- attached the navigation reference array on the iliac crest with schanz-screws.- performed a laminectomy, and placed a cage.- 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 not halted during this scan.- calibrated a pedicle access needle to the navigation.- placed the pedicle access needle with the aid of navigation, used a mallet on the needle, and inserted the k-wires.- inserted the pedicle screws with a non-navigated screwdriver following the k-wires.- completed the surgery.After the patient experienced leg pain, an unintended position of the right side l5 screw was detected with post-op ct scan on (b)(6) 2017.The other screw positions were correct as intended.A revision surgery was performed on (b)(6) 2017 (conventional with fluoro) to revise the one l5 screw.According to the hospital: - all screw positions were correct as intended after successful revision surgery.- there were no further negative effects on the patient, other than leg pain after original surgery resolved with (successful) revision surgery, neither due to screw placements nor additional surgery/anesthesia (of 1 hr 14 min).The patient did not need to return to surgery, and has needed no other surgical interventions.- there were no other remedial actions necessary, done or planned for this patient (other than screw correction done at revision surgery).- the patient arrived at the hospital the day of the revision surgery and was discharged the same day.

• 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; 81829 ; GM 81829
• Manufacturer Contact: markus hofmann ; olof-palme-strasse 9; GM 81829
• MDR Report Key: 6700078
• MDR Text Key: 80074043
• Report Number: 8043933-2017-00018
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• 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: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• 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