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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAINLAB AG CURVE NAVIGATION 17710 ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BRAINLAB AG CURVE NAVIGATION 17710 ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 17710
Device Problem Poor Quality Image (1408)
Patient Problem Insufficient Information (4580)
Event Date 11/24/2021
Event Type  Death  
Event Description
Discovered screw was placed in t1 instead of c7 per md "due to inaccuracy of image guidance system". An expert from brain lab came on site to evaluate the device with a mock surgery and stated "workflow error not software error.
 
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Brand NameCURVE NAVIGATION 17710
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BRAINLAB AG
5 westbrook corporate ctr ste 1000
westchester IL 60154
MDR Report Key12932980
MDR Text Key281738179
Report Number12932980
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number17710
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/01/2021
Date Report to Manufacturer12/06/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/06/2021 Patient Sequence Number: 1
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