REPLACE SELECT TAPERED PMC RP 4.3X11.5MM 37307

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 REPLACE SELECT TAPERED PMC RP 4.3X11.5MM 37307 manufactured by Nobel Biocare Usa Inc.

Event Text Entries

[185884518] Implant failed due to loss of osseointegration.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2027971-2020-08892
MDR Report Key9907581
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Event2020-01-13
Device Manufacturer Date2018-08-16
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 USA INC
Manufacturer Street22725 SAVI RANCH
Manufacturer CityYORBA LINDA CA 928874609
Manufacturer CountryUS
Manufacturer Postal Code928874609
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREPLACE SELECT TAPERED PMC RP 4.3X11.5MM
Generic NameENDOSSEOUS DENTAL IMPLANT
Product CodeDZE
Date Received2020-03-31
Catalog Number37307
Lot Number13069032
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNOBEL BIOCARE USA INC
Manufacturer Address22725 SAVI RANCH YORBA LINDA CA 928874609 US 928874609


Patients

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

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