LEGACY 2 IMPLANT 823210

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-11-30 for LEGACY 2 IMPLANT 823210 manufactured by Implant Direct Sybron Manufacturing Llc.

MAUDE Entry Details

Report Number3001617766-2019-05538
MDR Report Key9392147
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2019-11-30
Date of Report2019-11-29
Date of Event2019-08-10
Date Mfgr Received2019-11-13
Device Manufacturer Date2017-06-28
Date Added to Maude2019-11-30
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 ContactMRS ADRIENNE STOTT
Manufacturer Street3050 EAST HILLCREST DRIVE
Manufacturer CityTHOUSAND OAKS CA 91362
Manufacturer CountryUS
Manufacturer Postal91362
Manufacturer Phone8184443300
Single Use3
Remedial ActionIN
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEGACY 2 IMPLANT
Generic NameDENTAL IMPLANT
Product CodeDZE
Date Received2019-11-30
Returned To Mfg2019-11-19
Catalog Number823210
Lot Number96737
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerIMPLANT DIRECT SYBRON MANUFACTURING LLC
Manufacturer Address3050 EAST HILLCREST DRIVE THOUSAND OAKS CA 91362 US 91362


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-30

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