NOBELACTIVE 3.0 3.0X11.5MM 36770

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for NOBELACTIVE 3.0 3.0X11.5MM 36770 manufactured by Nobel Biocare Ab.

Event Text Entries

[185843231] Implant failed due to a failure to osseointegrate.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9611993-2020-20140
MDR Report Key9907641
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Event2020-01-27
Device Manufacturer Date2019-09-18
Date Added to Maude2020-03-31
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 ContactWILLEM VAN ALST
Manufacturer StreetKOZAKKENBERG 4
Manufacturer CityBELFELD 5951DL
Manufacturer CountryNL
Manufacturer Postal5951 DL
Manufacturer Phone683284947
Manufacturer G1NOBEL BIOCARE AB
Manufacturer StreetDIMBOV
Manufacturer CityKARLSKOGA 69151
Manufacturer CountrySE
Manufacturer Postal Code69151
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNOBELACTIVE 3.0 3.0X11.5MM
Generic NameENDOSSEOUS DENTAL IMPLANT
Product CodeDZE
Date Received2020-03-31
Catalog Number36770
Lot Number12141409
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNOBEL BIOCARE AB
Manufacturer AddressDIMBOV?GEN 2 KARLSKOGA 69151 SE 69151


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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