SIMPLY INTERACTIVE IMPLANT 654311U

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-11-30 for SIMPLY INTERACTIVE IMPLANT 654311U manufactured by Implant Direct Sybron Manufacturing Llc.

MAUDE Entry Details

Report Number3001617766-2019-05562
MDR Report Key9392167
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-11-30
Date of Report2019-11-29
Date of Event2019-11-11
Date Mfgr Received2019-11-14
Device Manufacturer Date2018-09-28
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
Reporter OccupationDENTIST
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 NameSIMPLY INTERACTIVE IMPLANT
Generic NameDENTAL IMPLANT
Product CodeDZE
Date Received2019-11-30
Catalog Number654311U
Lot Number125013
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
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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