INTERACTIVE SMARTBASE 6534-82

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 2020-03-06 for INTERACTIVE SMARTBASE 6534-82 manufactured by Implant Direct Sybron Manufacturing Llc.

Event Text Entries

[182510263] Included na for patient identifier and other relevant history to indicate not applicable.
Patient Sequence No: 1, Text Type: N, H10


[182510264] (b)(4), the udi number on the product label was incorrect. This is an internal complaint, there was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3001617766-2020-01904
MDR Report Key9800307
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-06
Date of Report2020-03-06
Date Mfgr Received2020-02-12
Device Manufacturer Date2017-02-02
Date Added to Maude2020-03-06
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
Manufacturer CountryUS
Manufacturer Phone4443300357
Single Use3
Remedial ActionIN
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTERACTIVE SMARTBASE
Generic NameDENTAL IMPLANT
Product CodeNHA
Date Received2020-03-06
Model Number6534-82
Catalog Number6534-82
Lot Number90108
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 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-06

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