UNK CEMENT RESTRICTOR/PLUG

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 2019-11-19 for UNK CEMENT RESTRICTOR/PLUG manufactured by Depuy Cmw - 9610921.

MAUDE Entry Details

Report Number1818910-2019-116959
MDR Report Key9342709
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-19
Date of Report2019-10-22
Date Mfgr Received2019-10-22
Date Added to Maude2019-11-19
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 Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal Code465810988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNK CEMENT RESTRICTOR/PLUG
Generic NameHIP MISCELLANEOUS : CEMENT RESTRICTOR/PLUG
Product CodeLZN
Date Received2019-11-19
Catalog NumberUNK CEMENT RESTRICTOR/PLUG
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY CMW - 9610921
Manufacturer AddressCORNFORD RD BLACKPOOL FY4 4QQ UK FY4 4QQ


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-19

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