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U.S. Department of Health and Human Services

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

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BRAINLAB AG SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 2.6) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 22268A
Device Problem Use of Device Problem (1670)
Patient Problem Thrombus (2101)
Event Date 05/04/2020
Event Type  Injury  
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 with navigation involved, and the vertebral artery was perforated, and according to the surgeon: although a postoperative ct angiogram showed that there was still blood flow through the vessel. Although so far the outcome of the surgery has been favorable, there are also no signs of myelopathy and no signs of a stroke. Status (b)(6) 2020: the patient is at persistent risk of a brainstem stroke from thrombosis of the vertebral artery, pt. Is being treated with aspirin as an antiplatelet. Although the screw was not corrected, neither at this surgery nor after, and there was no prolong of surgery or anesthesia at this surgery. Hospitalization has also not been prolonged for this patient. According to the results of the brainlab investigation and the information provided by the surgeon, it can be concluded that the root cause of the inaccurate placement of the navigated screw at right c2 can be attributed to a combination of one or more of the following potential factors: a relative movement of the vertebra operated on (c2) in relation to the reference array placement on the head holder, when applying forces on the bones during the surgery. Any movement of the patient's bone anatomy relative to the position of the reference array cannot be recognized nor compensated by the navigation. A less than ideal registration point acquisition by the user, that could have resulted in a less-than-ideal registration accuracy that was accepted for use with navigation. Apparently, a potential resulting deviation of the navigation display was either not clinically relevant or was not recognized by the surgeon before the navigated surgical actions, during the necessary accuracy verification after registration and throughout the procedure. A possible deviation of the non-navigated screw/screwdriver from the prepared path in the bone when placing the screw. Since this surgical step of actual screw placement was not navigated, there is no contribution by the brainlab device (navigation) for any potential deviation caused by this specific step. 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 fusion c2-c7, was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 2. 6 to prepare the pilot hole for the right c2 screw only. During the procedure the surgeon: fixated the patient's head in a non-brainlab head holder and attached the navigation reference array to the head holder. Acquired registration points on c2 to match the current patient anatomy to the ct scan of the patient imported and displayed by the navigation, verified and accepted the image registration to use navigation. Used the navigated pointer, and the navigated drill guide 2. 6mm for the drill bit open the cortical bone and prepare the pilot hole in right c2. Selected a shorter screw than originally thought to avoid the vertebral artery, and placed the screw in the prepared c2 pilot hole with a not navigated non-brainlab screwdriver. After further screw placements, a verification c-arm scan was performed, and revealed that the screw in c2 perforated the vertebral artery, with the screw deviating in its craniocaudal access (brainlab rough estimation of deviation is ca. 3mm). According to the surgeon: the vertebral artery was perforated by the screw placed in right c2. A postoperative ct angiogram showed that there was still blood flow through the vessel. So far the outcome of the surgery has been favorable, there are also no signs of myelopathy and no signs of a stroke. Status (b)(6) 2020: the patient is at persistent risk of a brainstem stroke from thrombosis of the vertebral artery, pt. Is being treated with aspirin as an antiplatelet. The screw was not corrected, neither at this surgery nor after, and there was no prolong of surgery or anesthesia at this surgery. Hospitalization has also not been prolonged for this patient.
 
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Brand NameSPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 2.6)
Type of DeviceIMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
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
markus hofmann
olof-palme-strasse 9
muenchen, 81829
GM   81829
MDR Report Key10090836
MDR Text Key197345070
Report Number8043933-2020-00024
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22268A
Device Catalogue Number22268A
Device Lot NumberSW V. 2.6
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 Received05/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2016
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: 05/27/2020 Patient Sequence Number: 1
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