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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, PRODUCT CODE: OLO

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BRAINLAB AG SPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 1.5) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC, PRODUCT CODE: OLO Back to Search Results
Model Number 22268-01C
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 03/11/2022
Event Type  Injury  
Event Description
A minimally-invasive surgery (on (b)(6) 2022) on the spine for transforaminal lumbar interbody fusion (tlif) at vertebrae l4 - l5, as a revision of a previous surgery (laminectomy l4), with intended placement of 4 pedicle screws, was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 1. 5. 1. During the procedure the surgeon: with the patient in prone position, attached the navigation reference clamp and 4-sphere array at the spinous process of vertebra l3. Prepared acquisition of an intra-operative ct scan (during this step the table was moved minimally in height in between structure detection and performing the scan). Acquired the intra-operative ct scan with automatic image registration of the current patient anatomy to the navigation, verified registration accuracy and accepted it to proceed. Opened the cortical bone using a navigated non-brainlab ("all-in-one") screwdriver. Placed screws by planning screw trajectories using the navigated brainlab pointer and inserting screws using the navigated non-brainlab screwdriver. After placement of three screws (l4 right, l5 right, l4 left) realized a deviation for the last one (l5 left) (the expected grip on bone was not observed). Decided to insert also the last screw and to verify screw positions using x-ray. Acquired an x-ray and detected that three screws were not placed as intended (only the position of the first screw inserted was considered clinically acceptable although not placed perfectly). Removed the three screws and replaced them with aid of x-rays. Ended surgery. According to the hospital/surgeon: the three screws not placed as intended using navigation were corrected in the very same surgery (with aid of x-rays). The outcome of the surgery was successful as intended, at the end of the surgery all screws were placed in their correct final positions as intended. There was no direct (or increased) risk of harm to a critical structure due to the unintended placements. There was no actual harm/negative clinical effect to the patient due to this issue (also not due to the prolongation of anesthesia/surgery time of 2 hours). No further medical/surgical remedial actions were necessary, done or planned for this patient due to this issue; hospitalization was not prolonged either.
 
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 brainlab navigation involved, despite according to the hospital/surgeon: the three screws not placed as intended using navigation were corrected in the very same surgery (with aid of x-rays). The outcome of the surgery was successful as intended, at the end of the surgery all screws were placed in their correct final positions as intended. There was no direct (or increased) risk of harm to a critical structure due to the unintended placements. There was no actual harm/negative clinical effect to the patient due to this issue (also not due to the prolongation of anesthesia/surgery time of 2 hours). No further medical/surgical remedial actions were necessary, done or planned for this patient due to this issue; hospitalization was not prolonged either. According to the results of the technical investigation and the information provided by the hospital, it can be concluded that the root cause for the reported misplaced screws (right/left l4 and left l5) by ca. 1cm from their intended positions is a movement of the registration matrix during the time when the structure detection was performed and the intra-operative scan was acquired (i. E. After the brainlab software stored the relative positions of the reference array and registration matrix in relation to each other in the 3-dimenstional space and before the scan was performed). Due to the significant time (over 20 mins) between these steps, inadvertent applied forces (e. G. Close/direct contact of cable/equipment on the array, drape resting on the array geometries, and re-positioning of the operating table) likely caused an inaccurate registration of the scan to the current patient anatomy. An additional factor that likely contributed to the reported inaccuracy was relative movement of the anatomy between the vertebrae operated on (l4 and l5) and where the reference was placed (l3). Operating on a different vertebra than the reference array is fixated to or operating over multiple vertebrae without repositioning the reference array and reregistering the patient, especially over a spine instability (e. G. Previous laminectomy performed on l4) and while using instruments that require high forces (e. G. Non-brainlab screwdriver) can cause anatomical movements between vertebrae that cannot be recognized or compensated by the navigation software, thus resulting in navigation inaccuracies. Apparently, the resulting deviation of the registered patient image in the navigation display from the actual patient anatomy was not recognized by the surgeon with the appropriate and necessary accuracy verification prior to accepting the registration, screw preparation and placement of the affected pedicle screws. 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.
 
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Brand NameSPINE & TRAUMA 3D NAVIGATION SOFTWARE (VERSION 1.5)
Type of DeviceIMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC, PRODUCT CODE: OLO
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 Key14039589
MDR Text Key291486754
Report Number8043933-2022-00019
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K183605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22268-01C
Device Catalogue Number22268-01C
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/25/2021
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: 04/07/2022 Patient Sequence Number: 1
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