MAUDE Adverse Event Report: BRAINLAB AG SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 2.6) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22268A

Device Problem Insufficient Information (3190)

Patient Problems Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Numbness (2415)

Event Date 09/05/2017

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since apparently 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. 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. Based on the information received to date, it cannot be confirmed that an actual inaccuracy of the information provided by brainlab navigation occurred, nor that the usage of the brainlab device contributed to an undesired surgery outcome. Brainlab plans to issue a follow-up report to the fda upon completion of investigation.

Event Description

A surgery on the spine for lumbar fusion at l2-l4 was performed with the aid of the brainlab navigation software spine&trauma 3d 2. 6 (on (b)(6) 2017). During the procedure the surgeon: positioned the patient in prone position on the or table. Attached the 2-pin fixator (with 3 sphere reference array) at the iliac crest. Performed the initial patient registration on the pre-operative ct scan (acquired using the airo) to match the display of the navigation to the current patient anatomy. Verified the accuracy of the registration. Placed k-wires / screws using aid of navigation. According to the information received, the patient experienced pain after the surgery, and subsequent imaging indicated that one screw was pressing on the l2 nerve root. On (b)(6) 2017, a revision surgery was performed for this specific patient (unknown which steps were performed in this surgery, and unconfirmed whether aid of brainlab navigation was used). After the revision surgery, the patient continued to have pain and numbness, and a third surgery was performed on (b)(6) 2017 (unconfirmed whether aid of brainlab navigation was used in this surgery). During this (3rd) procedure the surgeon: removed pedicle screws from l1 to the sacrum, and noted that the screws at l5-s1 did not have good purchase. During laminectomy, encountered and addressed a csf leak, and removed a small intradural hematoma. Placed pedicle screws at l1, l4, l5 and s1. Performed interbody fusion at l2-l3 (found that l2 nerve root appeared to be intact; removed a subligamentous disc herniation). Placed transverse connectors and applied bone graft from l1 to the sacrum. Placed a hemovac drain and a spinal cord stimulator in the dorsal epidural space from t8-t9. According to the information received, subsequently, the patient developed a severe infection which required antibiotics and a wound vac (vacuum-assisted closure of a wound).

• 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: 9068954
• MDR Text Key: 162985006
• Report Number: 8043933-2019-00042
• 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,other

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 22268A
• Device Catalogue Number: 22268A
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/18/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2016
• 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: 09/16/2019 Patient Sequence Number: 1