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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 Problems Use of Device Problem (1670); Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/16/2019
Event Type  Injury  
Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since allegedly screws were placed in the patient's spine in a different position than desired with navigation involved. Clarifications on the surgery with the hospital/surgeon are ongoing, currently: there was no harm or negative effect to the patient reported due to the alleged deviating screw placements, neither due to prolong of surgery/anesthesia. There were further no remedial actions reported necessary, done or planned for this patient. Hospitalization was not reported prolonged either. 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.
 
Event Description
An open surgery on the spine for fusion of vertebrae with intended placement of pedicle screws, was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 2. 6. A pre-surgery ct scan to use with navigation was acquired a day before this surgery. Allegedly, pedicle screws placed at this surgery deviated from the desired and intended positions. Clarifications on the surgery with the hospital/surgeon are ongoing, currently: there was no harm or negative effect to the patient reported due to the alleged deviating screw placements, neither due to prolong of surgery/anesthesia. There were further no remedial actions reported necessary, done or planned for this patient. Hospitalization was not reported prolonged either.
 
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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 Key8619565
MDR Text Key145484317
Report Number8043933-2019-00024
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeGR
PMA/PMN Number
K070106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2019
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2018
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: 05/17/2019 Patient Sequence Number: 1
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