SURGICASE O-01-0-101000-0011-010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-11-22 for SURGICASE O-01-0-101000-0011-010 manufactured by Materialise Usa, Llc.

MAUDE Entry Details

Report Number3005718816-2019-00001
MDR Report Key9361713
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-11-22
Date of Report2019-10-30
Date of Event2019-07-11
Date Mfgr Received2019-10-30
Device Manufacturer Date2019-07-07
Date Added to Maude2019-11-22
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 ContactMS JENNY JONES
Manufacturer StreetTECHNOLOGIELAAN 15
Manufacturer CityLEUVEN, VLAAMS BRABANT 3001
Manufacturer CountryBE
Manufacturer Postal3001
Manufacturer G1MATERIALISE USA, LLC
Manufacturer Street44650 HELM COURT
Manufacturer CityPLYMOUTH MI 48170
Manufacturer CountryUS
Manufacturer Postal Code48170
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSURGICASE
Generic NameSURGICASE GUIDE
Product CodePBF
Date Received2019-11-22
Model NumberO-01-0-101000-0011-010
Catalog NumberO-01-0-101000-0011-010
Lot NumberOO19UDEHEZ
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMATERIALISE USA, LLC
Manufacturer Address44650 HELM COURT PLYMOUTH MI 48170 US 48170


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-22

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