CRANIAL NAVIGATION SOFTWARE (VERSION 3.1) 22216-02 19900

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-29 for CRANIAL NAVIGATION SOFTWARE (VERSION 3.1) 22216-02 19900 manufactured by Brainlab Ag.

MAUDE Entry Details

Report Number8043933-2019-00061
MDR Report Key9391935
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-29
Date of Report2019-09-18
Date of Event2019-09-16
Date Mfgr Received2019-09-18
Device Manufacturer Date2017-03-01
Date Added to Maude2019-11-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. MARKUS HOFMANN
Manufacturer StreetOLOF-PALME-STRASSE 9
Manufacturer CityMUENCHEN, 81829
Manufacturer CountryGM
Manufacturer Postal81829
Manufacturer G1BRAINLAB AG
Manufacturer StreetOLOF-PALME-STRASSE 9
Manufacturer CityMUENCHEN, 81829
Manufacturer CountryGM
Manufacturer Postal Code81829
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCRANIAL NAVIGATION SOFTWARE (VERSION 3.1)
Generic NameIMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
Product CodeHAW
Date Received2019-11-29
Model Number22216-02
Catalog Number19900
Lot NumberSW V. 3.1.1
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBRAINLAB AG
Manufacturer AddressOLOF-PALME-STRASSE 9 MUENCHEN, 81829 GM 81829


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other 2019-11-29

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