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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); Insufficient Information (3190)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
A spine surgery to place screws into the spinal vertebrae was performed with the aid of the display by the brainlab navigation software spine&trauma 3d 1. 5. During the procedure a screw placement was performed in another location than intended with the brainlab device involved, and there could have led to harm of the spinal cord and/or blood vessels, and thus in a worst case scenario ultimately to serious harm to the patient. The screw was replaced (repositioned) during the same surgery. To date, no harm/negative clinical effect to the patient was reported to brainlab due to this issue, nor any medical/surgical remedial actions that would have been necessary, done or planned for this patient due to this issue. Brainlab has requested further information from the customer.
 
Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since apparently a screw placement was performed in another location than intended with the brainlab device involved, and therewith could have led to harm of the spinal cord and/or blood vessels, and thus in a worst case scenario ultimately to serious harm to the patient, although: the hospital did not report any negative clinical effects for this specific patient due to this issue nor any further remedial actions (besides replacement of the screw during the same surgery) that would have been necessary. Currently there is no indication of a systematic error or malfunction of the brainlab device, nor of insufficient measures to minimize this anticipated risk as low as reasonably practicable 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
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 Key13535914
MDR Text Key289982320
Report Number8043933-2022-00009
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K183605
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22268-01C
Device Catalogue Number22268-01C
Device Lot NumberSW V. 1.5.1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2020
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: 02/15/2022 Patient Sequence Number: 1
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