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); Insufficient Information (3190)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since screw(s) were placed in another location than intended in the spine, with the brainlab device involved, and therewith could have led to harm of the spinal cord and/or blood vessels, and thus in a worst case scenario ultimately to serious harm to the patient, although: the outcome of the revision surgery was successful (surgeon was satisfied with placement of all screws). The hospital did not report any negative clinical effects for this specific patient due to this issue nor any further remedial actions (besides revision surgery) that would have been necessary. Currently there is no indication of a systematic error or malfunction of the brainlab device, nor of insufficient measures to minimize this anticipated risk as low as reasonably practicable. A comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending. Brainlab plans to issue a follow-up report to the fda upon completion of investigation.

Event Description

A surgery on the spine for l5-s1 posterior fusion was performed with the aid of the brainlab navigation software spine&trauma 3d 2. 6 (on (b)(6) 2019). A ct scan was acquired (using the airo), whereby 'supine' was selected instead of 'prone' at the scanner console (airo pendant) by the ct technician. During the procedure the surgeon: verified the accuracy of the patient registration (that matches the display of the ct scan, imported into the navigation, to the current patient anatomy) and accepted the result: placed 4 screws. Obtained a control scan to verify screw placement, and decided to adjust the placement of one screw: verified registration accuracy during the procedure, and was made aware that right and left looked switched and was asked to stop. Was informed that incorrect patient positioning information had been entered at the ct. Scanner: rescanned the patient (with correct patient positioning information). Verified registration accuracy and replaced one screw. Obtained another control scan to verify screw placement and was satisfied with the position of all screws. On the following day ((b)(6) 2019), the surgeon decided to replace one screw (unknown if same screw or other screw) since its position was determined to be slightly too medial. A revision surgery was scheduled for (b)(6) 2019, and the screw was replaced successfully. A control scan was obtained, and the surgeon was satisfied with the location of all screws. The hospital did not report any negative clinical effects for this specific patient due to this issue nor any further remedial actions (besides revision surgery) that would have been necessary.

• 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; münchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer Contact: andrea miller ; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• MDR Report Key: 8673685
• MDR Text Key: 147167170
• Report Number: 8043933-2019-00028
• Device Sequence Number: 1
• Product Code: HAW
• 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

• Type of Report: Initial,Followup
• Report Date: 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 22268A
• Device Catalogue Number: 71116A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 06/06/2019 Patient Sequence Number: 1