ANCHOR PLATE SIZE 46 114010046

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2020-03-04 for ANCHOR PLATE SIZE 46 114010046 manufactured by Depuy Orthopaedics Inc Us.

MAUDE Entry Details

Report Number1818910-2020-06876
MDR Report Key9788492
Report SourceFOREIGN,HEALTH PROFESSIONAL,S
Date Received2020-03-04
Date of Report2020-02-14
Date of Event2020-02-10
Date Mfgr Received2020-02-14
Device Manufacturer Date2018-05-31
Date Added to Maude2020-03-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
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 IRELAND - 9616671
Manufacturer StreetLOUGHBEG RINGASKIDDY CO.
Manufacturer CityCORK
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameANCHOR PLATE SIZE 46
Generic NameSHOULDER HUMERAL STEM ACCESSORY
Product CodeHSD
Date Received2020-03-04
Catalog Number114010046
Lot Number8775324
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS INC US
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-04

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