NORIAN DRILLABLE INJECT 10CC-STERILE 07.704.010S

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 2019-09-30 for NORIAN DRILLABLE INJECT 10CC-STERILE 07.704.010S manufactured by Wrights Lane Synthes Usa Products Llc.

MAUDE Entry Details

Report Number2939274-2019-61056
MDR Report Key9136165
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-09-30
Date of Report2019-09-05
Date of Event2019-09-05
Date Mfgr Received2019-09-05
Date Added to Maude2019-09-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 NameNORIAN DRILLABLE INJECT 10CC-STERILE
Generic NameFILLER, CALCIUM SULFATE PREFORMED PELLETS
Product CodeMQV
Date Received2019-09-30
Model Number07.704.010S
Catalog Number07.704.010S
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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
10 2019-09-30

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