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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 Muscle Weakness (1967)
Event Date 11/28/2019
Event Type  Injury  
Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since pedicle screws were placed in the patient's spine in a different position than desired with navigation involved, and the deviating 3 placements on the left side unintendedly placed into the spinal canal, led to dural tear and some mild left hip flexion weakness of the patient, although according to the surgeon: the surgeon detected the deviation of the screws before finalizing the surgery, and corrected these successfully with navigation at the very same surgery. Other than the placement correction at the surgery, there were no remedial actions done, necessary or planned for this patient. The final outcome of this surgery was successful as intended, with all placements correct at the end of the surgery. The prolong of surgery/anesthesia (of ca. 2-3h) for placement corrections did not cause any negative effect to the patient. Hospitalization was extended for this patient, yet this was not related to the spinal canal breach. According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the main root cause for the deviation of the 3 placements on the left side vertebrae l2-l4, by ca. 5-10mm medially, is a relative movement of the vertebrae operated on in relation to the reference array fixated on the left iliac crest, due to application of high forces including a mallet for opening the cortical bones with the navigated instrument. These relative movements when applying forces during the surgery led to a shift between the navigation display of the (pre-placement) image data set and actual current patient anatomy. These vertebrae movements relative to the navigation reference array during e. G. Hardware placement, cannot be recognized by the navigation system when displaying tracked instrument positions on the registered image. 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
A minimally invasive surgery for fusion of the lumbar spine (2nd procedure after former 3 level xlif), with intended placement of 8 k-wires and following pedicle screws bilateral in vertebrae l2-l5, was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 2. 6. During the procedure the surgeon: attached the navigation reference array on the iliac crest with 2 schanz pins and 2-pin fixator with the patient in prone position. Acquired an intra-operative (pre-surgery) ct scan with automatic image registration to match the display of the navigation to the current patient anatomy, verified the accuracy in the navigation and accepted the registration to proceed. Opened the cortical bone (pilot holes) on the right side in vertebrae l2-l5 with the navigated needle, and placed the corresponding 4 k-wires. Swapped the patient side, for pilot holes and the 4 k-wire placements on the left side of l2-l5. On the left side the surgeon encountered hard bone, and had to strongly use a mallet with difficulties to crack the cortical bone with the needle. Used a non-brainlab screwdriver calibrated to the navigation to place the 4 pedicle screws following the k-wires left l2-l5, and right l5. The surgeon detected that the navigation display of the screwdriver's position deviated from some k-wire positions, and re-calibrated the screwdriver with the deviation persisting. Decided to perform another intra-operative ct scan before placing the remaining screws on the right side. Determined from this scan that the positions of the 3 screws left l2-l4 deviated the intended positions by ca. 5-10mm medially and were placed into the spinal canal. The k-wires in right l2-l4 were placed ideally as intended, also the screws on both sides of l5 were placed correctly. Removed the 3 deviating left l2-l4 screws and re-placed these to the correct positions using further registered intra-op ct scans with navigation. When all screws were placed correctly as desired, completed the surgery successfully as intended. According to the surgeon: the surgeon detected the deviation of the screws before finalizing the surgery, and corrected these successfully with navigation at the very same surgery. The deviating 3 left placements unintendedly placed into the spinal canal, led to dural tear and some mild left hip flexion weakness of the patient. Other than the placement correction at the surgery, there were no remedial actions done, necessary or planned for this patient. The final outcome of this surgery was successful as intended, with all placements correct at the end of the surgery. The prolong of surgery/anesthesia (of ca. 2-3h) for placement corrections did not cause any negative effect to the patient. Hospitalization was extended for this patient, yet this was not related to the spinal canal breach.
 
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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 Key9479644
MDR Text Key188803902
Report Number8043933-2019-00065
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K183605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 11/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2017
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: 12/17/2019 Patient Sequence Number: 1
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