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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); Insufficient Information (3190)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2022
Event Type  Injury  
Event Description
An open surgery (on (b)(6) 2022 ) on the spine for c2-c4 fusion 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 array at c2. Performed the image registration (surface matching) to match the pre-operative ct and display of the navigation to the current patient anatomy, verified the registration and considered it inaccurate. Performed a second image registration, verified and accepted the registration, considering it to be acceptable for the procedure. Placed four screws using aid of navigation. Acquired an x-ray for verification of screw position and detected that the screw(s) placed in c2 deviate from their intended position (by 3-4 mm). Removed the screw(s) from c2. -continued the surgery without aid of navigation (but using fluoroscopy). According to the hospital/surgeon: the pedicle screw(s) not placed as intended with aid of navigation were removed in the very same surgery. There was no actual harm nor negative effect to the patient reported due to the deviating placement no further remedial actions for the patient were reported that would have been done, necessary or planned, nor was prolongation of hospitalization reported.
 
Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since pedicle screw(s) was/were positioned in the patient's spine in a different position than desired with brainlab navigation involved, although according to the hospital/surgeon: the pedicle screw(s) not placed as intended with aid of navigation were removed in the very same surgery. There was no actual harm nor negative effect to the patient reported due to the deviating placement. No further remedial actions for the patient were reported that would have been done, necessary or planned, nor was prolongation of hospitalization reported. A comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending. Brainlab plans to issue a follow-up report to the fda upon completion of investigation.
 
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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 Key13838356
MDR Text Key293143267
Report Number8043933-2022-00016
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2022
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 Received02/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2021
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: 03/21/2022 Patient Sequence Number: 1
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