MAUDE Adverse Event Report: BRAINLAB AG SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 1.5) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC, PRODUCT CODE: OLO

Model Number 22268-01C

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Unspecified Nervous System Problem (4426); Insufficient Information (4580)

Event Date 10/25/2021

Event Type  Injury  

Event Description

A spine surgery to place screws into the spinal vertebrae was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 1. 5. During the procedure a screw placement was performed in another location than intended 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. The screw was replaced (repositioned) during the same surgery. To date, no harm/negative clinical effect to the patient was reported to brainlab due to this issue, nor any medical/surgical remedial actions that would have been necessary, done or planned for this patient due to this issue. Brainlab has requested further information from the customer.

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a screw placed with the aid of navigation were not placed as intended and therewith could have led to harm of critical structures and/or blood vessels and thus ultimately to a serious injury of the patient, although: the hospital did not report any negative clinical effects for this specific patient due to this issue nor any further remedial actions (besides replacement of the screw during the same 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.

• Brand Name: SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 1.5)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC, PRODUCT CODE: OLO
• 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: maura boyle ; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 13192341
• MDR Text Key: 285564640
• Report Number: 8043933-2022-00003
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K183605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 22268-01C
• Device Catalogue Number: 22268-01C
• Device Lot Number: SW V. 1.5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 01/07/2022 Patient Sequence Number: 1