CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE 615.10.01S

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 2020-01-14 for CRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE 615.10.01S manufactured by Wrights Lane Synthes Usa Products Llc.

MAUDE Entry Details

Report Number2939274-2020-00176
MDR Report Key9587274
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-14
Date of Report2019-12-17
Date Mfgr Received2020-01-15
Device Manufacturer Date2016-05-16
Date Added to Maude2020-01-14
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 ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1MONUMENT
Manufacturer Street1101 SYNTHES AVENUE
Manufacturer CityMONUMENT CO 80132
Manufacturer CountryUS
Manufacturer Postal Code80132
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCRANIOS REINFORCED FAST SET PUTTY 10CC-STERILE
Generic NameMETHYL METHACRYLATE FOR CRANIPLASTY
Product CodeGXP
Date Received2020-01-14
Model Number615.10.01S
Catalog Number615.10.01S
Lot NumberDSD3815
Device Expiration Date2017-08-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWRIGHTS LANE SYNTHES USA PRODUCTS LLC
Manufacturer Address1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-14

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