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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 22268-01C
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 08/31/2021
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, although according to the surgeon: the deviation of the screws was detected by the surgeon after placement with a fluoroscopic control scan before finalizing the surgery, the screws were removed, and the surgeon decided to fill with graft and not replace the screws. There was no actual harm/negative clinical effect to the patient due to the incorrect placement of screws, nor for the prolonged anesthesia of 1 hour. There was no direct (or increased) risk of harm to a critical structure (e. G. Spinal cord, nerves, blood vessels, etc. ) due to the deviating screws. There were no other remedial actions for the patient done, necessary or planned. The surgeon has stated there will only be a revision surgery for placing screws if needed later, but there is no need for a revision surgery at this time. Hospitalization was not prolonged 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 screw misplacements, by approximately 3 - 4 mm from their intended (stored) trajectory and entering into the disc space, was most likely a movement of the patient reference array due to an insufficiently rigid fixation and/or inadvertently applied forces during the procedure after patient registration to navigation. A movement of the patient reference array after patient registration is performed disrupts the coordinate system established during registration and result in a deviation between the registered patient image and the actual anatomy at the procedure. A non-approved third party (non-brainlab) 1-pin fixator was used with brainlab navigation at this procedure. As brainlab does not have any information regarding this 1-pin fixator (e. G. Its manufacturer, design, stability, interface to brainlab reference array, etc. ) and this third party 1-pin fixator has not been officially tested or approved for use with brainlab navigation systems, brainlab cannot guarantee the stability and suitability of its use for accurate navigation. The deviation of all screws as seen in the patient scans as reviewed in this investigation also fits to a reference array movement. Movement of the patient reference array relative to the patient anatomy cannot be recognized nor compensated by the navigation software and will result in navigation inaccuracies. Apparently, the resulting deviation between the registered patient image and the patient anatomy was not recognized by the surgeon with the appropriate and necessary accuracy verification during verification of the registration (before accepting), and throughout the procedure, before and during use of the navigated instruments to perform invasive surgical steps at l5 - s1 (since no accuracy verification was performed at all on the registration and during navigation at the procedure). 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 minimally invasive surgery on the spine for an l5-s1 fusion, with intended placement of 4 pedicle screws for fixation, was performed with the aid of the display by the brainlab navigation software spine & trauma 3d 1. 5. During the procedure the surgeon: positioned the patient supine and performed an anterior lumbar interbody fusion (alif) including cage and anterior screw placement without the use of navigation. Positioned the patient in prone position and attached the brainlab reference array to a non-brainlab one-pin fixator which was pinned to the patient's left iliac crest. Acquired a 3d fluoroscopic scan using an intra-operative c-arm with automatic image registration of the current patient anatomy to the navigation, and accepted the registration to proceed without performing the necessary accuracy verification. Calibrated the brainlab pedicle access needle and a non-brainlab screwdriver to the navigation, and planned and stored screw trajectories in the navigation software. Navigated the pedicle access needle to the planned trajectory, prepared the screw path, inserted a k-wire, and then used the navigated screwdriver to place the screw over the k-wire into the pedicle for screws at left l5, left s1, right l5, and right s1. Performed a verification scan using the intra-operative c-arm and determined that the l5 screws had entered the disc space; the s1 screws were reportedly fine. Removed all screws and decided to instead fill the spine with graft, rather than replacing the screws. Completed the surgery. According to the surgeon: the deviation of the screws was detected by the surgeon after placement with a fluoroscopic control scan before finalizing the surgery, the screws were removed, and the surgeon decided to fill with graft and not replace the screws. There was no actual harm/negative clinical effect to the patient due to the incorrect placement of screws, nor for the prolonged anesthesia of 1 hour. There was no direct (or increased) risk of harm to a critical structure (e. G. Spinal cord, nerves, blood vessels, etc. ) due to the deviating screws. There were no other remedial actions for the patient done, necessary or planned. The surgeon has stated there will only be a revision surgery for placing screws if needed later, but there is no need for a revision surgery at this time. Hospitalization was not prolonged 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 Key12522201
MDR Text Key274229337
Report Number8043933-2021-00060
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
Type of Report Initial
Report Date 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22268-01C
Device Catalogue Number22268-01C
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 Received08/31/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2021
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: 09/23/2021 Patient Sequence Number: 1
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