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U.S. Department of Health and Human Services

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

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BRAINLAB AG NAVIGATION SOFTWARE SPINE & TRAUMA 3D (VERSION 2.6) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 22268A
Device Problems Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2016
Event Type  No Answer Provided  
Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since screws were placed in another position than intended with the brainlab device involved, although: - there is no indication of a systematic error or malfunction of the brainlab device. - corresponding measures to minimize this anticipated risk as low as reasonably practicable are already in place. - according to the hospital, the surgery was finished without harm to the patient and final screw placement was acceptable; no further remedial actions (besides revised screw in s1 left) were reported that would have been necessary. According to the results of brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the screws not placed as intended is a damaged navigated instrument (bent thoracic probe), leading to a discrepancy between the virtual display of navigation and the actual patient anatomy. (details: since the instrument calibration was successfully validated before its use, it is concluded that the probe was bent during preparation of the left pedicle of l5. Bending could occur due to lever forces if the instrument trajectory is adjusted without removing the instrument from the pedicle. ) further contributing factors: - a relative movement of the vertebra l5 in relation to the sacrum that could not be compensated by the navigation system, since the reference array was not placed on the vertebra to be operated on. - potential deviations that occurred during insertion of the screw, which was performed without aid of navigation (using a non-navigated screw driver). There is no indication of a systematic error or malfunction of the brainlab navigation device. Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place. Brainlab intends to: - inform this hospital about the investigation results. - corresponding to the root cause, brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.
 
Event Description
An open spine surgery for stabilization of l5 and s1 was planned to be performed with the aid of the brainlab navigation system spine & trauma 3d 2. 6. During the procedure the surgeon: - attached the navigation reference clamp to l5. - verified and accepted the patient registration (matching of virtual display of preoperative image dataset and actual patient anatomy). - placed screws in l5 left and s1 left with the aid of a navigated probe. - acquired a fluoroscopic image and detected that the screws were not placed as desired. - determined that position of the screw in l5 left was still acceptable, whereas the positon of the screw in s1 left was not (too lateral and close to the corticalis of the vertebrae) - further, realized (by visual inspection) that the used navigated probe was bent - decided to revise the screw in s1 left and to place the screws in l5 right and s1 right without aid of navigation (but using fluoroscopic images). According to the hospital, the surgery was finished without harm to the patient and final screw placement was acceptable; no further remedial actions (besides revised screw in s1 left) were reported that would have been necessary.
 
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Brand NameNAVIGATION SOFTWARE SPINE & TRAUMA 3D (VERSION 2.6)
Type of DeviceIMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
BRAINLAB AG
kapellenstrasse 12
feldkirchen, 85622
GM 85622
Manufacturer (Section G)
BRAINLAB AG
kapellenstrasse 12
feldkirchen, 85622
GM 85622
Manufacturer Contact
andrea miller
kapellenstrasse 12
feldkirchen, 85622
GM   85622
89 9915680
MDR Report Key6192536
MDR Text Key62905124
Report Number8043933-2016-00042
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K070106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22268A
Device Catalogue Number22268A
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 Received12/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2016
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: 12/21/2016 Patient Sequence Number: 1
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