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 Hemorrhage/Bleeding (1888)

Event Date 07/10/2017

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 in the patient's cervical spine in a different position than desired, and into the foramen of the arteria vertebralis, with the brainlab device involved, although according to the surgeon: - the bleeding was detected immediately during the surgery and was addressed.- there is no revision surgery necessary, the stabilization is acceptable.- as a preventive measure after the bleeding occurred, blood thinning medication was started for the patient (planned for 3 months, with surveillance of patient), and hospitalization was prolonged for 3 days due to this issue.- there are no other negative effects to the patient reported, nor further necessary remedial actions, neither due to delay of anesthesia of ca.5-10 mins.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 cervical pedicle screw position is a combination of the not navigated screw placement (with non-navigated screwdriver) not perfectly following the prepared channel in bone with osteoporosis, with additionally for the bone channel preparation a less than ideal patient anatomy registration for navigation using a less than ideal pre-op ct scan, contributing to the small deviation of the resulting screw angle -with deviation smaller than 10°, but relevant for this cervical spine surgery.Apparently, this has not been recognized with the necessary continued verification of navigation accuracy by the user.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 open surgery on the cervical spine for a fusion for a fracture of c2 (2 pedicle screws), was performed with the aid of the virtual display by the brainlab navigation software spine&trauma 3d 2.6.The patient also had osteoporosis.A pre-operative ct scan was acquired at the day of surgery to use with navigation.During the procedure the surgeon: - positioned the patient in prone position on the or table.- attached the navigation reference array to c2.- performed the initial patient registration on the pre-op ct with registration points taken on c2 to match the virtual display of the navigation to the current patient anatomy.- verified the accuracy of the registration and decided to acquire further registration points - verified the accuracy of registration again to be acceptable for use.- verified the pre-calibrated brainlab drill guide 2.6mm for the navigation.- prepared the bone channels (pedicle holes) in c2 with the aid of the navigated drill guide.- inserted the pedicle screws with a non-navigated screwdriver following the bone channels.- detected a per-operative bleeding (from arteria vertebralis) and repaired the artery immediately during the same surgery.- completed the surgery.A post-op scan confirmed the bleeding that had occurred, and showed that one screw in c2 was not placed as intended (deviation of less than 10°), with tip ca.3-4mm deviating from intended position, tip placed under the pedicle to the foramen of the arteria vertebralis.The other screw placed in c2 was placed correctly as intended, as confirmed with the post-op scan.According to the surgeon: - the bleeding was detected immediately during the surgery and was addressed.- there is no revision surgery necessary, the stabilization is acceptable.- as a preventive measure after the bleeding occurred, blood thinning medication was started for the patient (planned for 3 months, with surveillance of patient).- hospitalization was prolonged for 3 days due to this issue.- there are no other negative effects to the patient reported, nor further necessary remedial actions, neither due to delay of anesthesia of ca.5-10 mins.

• 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: 6739761
• MDR Text Key: 80904844
• Report Number: 8043933-2017-00021
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481106591
• UDI-Public: 04056481106591
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 07/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 22268A
• Device Catalogue Number: 71116A
• 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: 07/11/2017
• 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): Hospitalization; Other; Required Intervention