CARRIERE MOTION CLASS II 17MM RIGHT 424-917RN

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 2017-09-05 for CARRIERE MOTION CLASS II 17MM RIGHT 424-917RN manufactured by Ortho Organizers, Inc.

Event Text Entries

[84945430] Instructions for use and quick start guide both specifically state that the cuspid or bicuspid pad is to be debonded first, followed by debonding the molar pad. In this instance, the device was removed by debonding the molar pad first, then attempting to debond the bicuspid pad.
Patient Sequence No: 1, Text Type: N, H10


[84945511] While the technician was removing carriere motion class ii 17 mm right device, maxillary 1st bicuspid fractured. In addition the tooth fracturing, the pliers that were being used were broken during the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2081322-2017-00004
MDR Report Key6843863
Report SourceHEALTH PROFESSIONAL
Date Received2017-09-05
Date of Report2017-09-05
Date of Event2017-08-17
Date Mfgr Received2017-08-17
Date Added to Maude2017-09-05
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 ContactMARY PEARMAN
Manufacturer Street1822 ASTON AVENUE
Manufacturer CityCARLSBAD CA 92008
Manufacturer CountryUS
Manufacturer Postal92008
Manufacturer G1ORTHO ORGANIZERS, INC
Manufacturer Street1822 ASTON AVENUE
Manufacturer CityCARLSBAD CA 920087306
Manufacturer CountryUS
Manufacturer Postal Code920087306
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARRIERE MOTION CLASS II 17MM RIGHT
Generic NameBRACKET, METAL, ORTHODONTIC
Product CodeEJF
Date Received2017-09-05
Returned To Mfg2017-08-23
Model Number424-917RN
OperatorDENTAL ASSISTANT
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerORTHO ORGANIZERS, INC
Manufacturer Address1822 ASTON AVENUE CARLSBAD CA 920087306 US 920087306


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-09-05

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