SIMPLYLEGACY DRIVER HT2.0SG

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 2020-02-14 for SIMPLYLEGACY DRIVER HT2.0SG manufactured by Implant Direct Sybron Manufacturing Llc.

Event Text Entries

[179415982] Lot information unknown and if it becomes available a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[179415983] Per complaint (b)(4), during clinical procedure, driver broke off in the implant.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3001617766-2020-01467
MDR Report Key9710738
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-02-14
Date of Report2020-02-14
Date Mfgr Received2020-01-24
Date Added to Maude2020-02-14
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
Manufacturer CountryUS
Manufacturer Phone4443300357
Single Use3
Remedial ActionIN
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSIMPLYLEGACY DRIVER
Generic NameDENTAL IMPLANT
Product CodeNDP
Date Received2020-02-14
Returned To Mfg2020-02-03
Model NumberHT2.0SG
Catalog NumberHT2.0SG
Lot NumberNI
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 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-14

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