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U.S. Department of Health and Human Services

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

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BRAINLAB AG SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 1.5) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 22268-02A
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2021
Event Type  Injury  
Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since a screw was placed in the patient's spine in a different position than desired with the brainlab device involved, despite according to the surgeon: the deviation of the screw was detected by the surgeon with 2d fluoroscopy before completing the surgery, and the screw was replaced (repositioned) successfully at the very same surgery. The outcome of the surgery was successful as intended, with all screws placed correctly at the end of the surgery. There was no harm/negative clinical effect to the patient due to the screw placement, nor for the prolongation of anesthesia by a few minutes. There were no further medical/surgical remedial actions necessary, done, or planned for this patient. There was no report of any prolonged hospitalization either. According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause of the misplaced screw placement at left c2 by approximately 4 mm caudal from its intended position was most likely a combination of one or more of the following potential factors: the use of an instrument array that is too small for the screwdriver instrument being calibrated in navigation. The smallest available array (m-size) was used to calibrate the non-brainlab screwdriver, which is intended to be used with the l-size array. The resulting screwdriver calibration accuracy was not within the software's acceptable limits and a warning dialog was displayed to the user, though the user ignored the warning and accepted it knowing that its calibration accuracy may be less precise. A less than optimal patient scan that did not completely follow brainlab scan protocols for surface matching registration (a non-recommended low dose and soft tissue reconstruction were used) could have caused the software to not find an as accurate match as desired at the region of interest for this procedure, between the preoperative image dataset and actual patient anatomy. Difficult patient anatomy at left c2: a steeply angled or tilted bone may have increased the likelihood of potential slipping/shifting of the instrument on the bone (away from its intended position) and/or unintentional adjustment of the instrument's angle during an invasive surgical step. Poor bone quality could have also led to unintentional deviation of the instrument/screw from its intended path in the bone. Apparently, the resulting deviation of the tracked instruments on the registered preoperative image in the navigation display compared to the actual patient anatomy was not detected by the user with the necessary and appropriate accuracy verification during the verification step (directly after registration and prior to accepting) or throughout the procedure during preparation and placement of the left c2 screw. 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 reiterate the relevant topics regarding the use of the device to this customer.
 
Event Description
A surgery on the spine for a fusion with screws planned from c0 (occipital bone) to either t1 or t2, for a patient with a history of rheumatoid arthritis with an unstable cervical spine (and additional myelopathy), was performed with the aid of the display by the brainlab navigation software spine & trauma 3d (b)(4). During the procedure the surgeon: positioned the patient in prone position on the or table. Inserted four screws at c0 (occipital bone) without using navigation. Attached the navigation reference array on vertebra c2. Performed registration using the navigated pointer to acquire registration points on the patient's bone at c2 to match the display of the navigation to the current patient anatomy. The surgeon verified and accepted the registration to proceed. Calibrated a non-brainlab drill guide and non-brainlab screwdriver to the navigation and verified and accepted the calibration to proceed. The brainlab navigation software displayed a warning dialog that the accuracy of the calibration of the screwdriver exceeded the software's tolerances, but the user acknowledged and accepted the calibration by selecting the ignore button on this message to proceed. Used the navigated drill guide and navigated screwdriver to create a path in the bone and place a screw at left c2, respectively. Detected via 2d fluoroscopic image that the screw at left c2 was not placed as intended, deviating 4mm caudal from its intended position. Replaced (repositioned) the left c2 screw successfully to its intended position using fluoroscopic guidance, without navigation. Calibrated a second non-brainlab drill guide to the navigation and verified and accepted the calibration to proceed. Used the newly calibrated drill guide and screwdriver to create a path in the bone and place a screw at right c2. Placed lateral mass screws at both sides of c3, c4, and c5 without navigation. Removed the patient reference array from c2 and attached it on c7, and performed a new registration using the navigated pointer to acquire registration points on the patient's bone at c7 to match the display of the navigation to the current patient anatomy. The surgeon verified and accepted the registration to proceed. Recalibrated the first non-brainlab drill guide to the navigation and verified and accepted the calibration to proceed. Used this navigated drill guide and the navigated screwdriver to create paths in the bone and place pedicle screws respectively at both sides of c7. Completed the surgery successfully as intended. According to the surgeon: the deviation of the screw was detected by the surgeon with 2d fluoroscopy before completing the surgery, and the screw was replaced (repositioned) successfully at the very same surgery. The outcome of the surgery was successful as intended, with all screws placed correctly at the end of the surgery. There was no harm/negative clinical effect to the patient due to the screw placement, nor for the prolongation of anesthesia by a few minutes. There were no further medical/surgical remedial actions necessary, done, or planned for this patient. There was no report of any prolonged hospitalization either.
 
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Brand NameSPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 1.5)
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
maura boyle
olof-palme-strasse 9
muenchen, 81829
GM   81829
MDR Report Key11596800
MDR Text Key260791128
Report Number8043933-2021-00021
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K183605
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 03/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22268-02A
Device Catalogue Number26663A
Device Lot NumberSW V. 1.5.1
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 Received03/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2020
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: 03/31/2021 Patient Sequence Number: 1
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