DAMON CLEAR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-05-20 for DAMON CLEAR manufactured by Ormco Corporation.

Event Text Entries

[18202981] The patient's tooth was repaired and a new damon clear bracket was placed. The patient is doing fine. The doctor stated that the bracket was placed in the middle of the tooth and an etm bracket removal plier, and not a damon clear debonding instrument as recommended in the damon clear debonding protocol, was used to debond the bracket. It can therefore be concluded that user error contributed to this incident. No product was returned for evaluation and no part number or lot number were provided therefore no further investigation can take place.
Patient Sequence No: 1, Text Type: N, H10


[18373520] On (b)(6), 2011, a doctor reported to ormco corporation that a patient experienced enamel loss upon debonding a damon clear bracket.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2016150-2011-00093
MDR Report Key2098193
Report Source05
Date Received2011-05-20
Date of Report2011-04-25
Date Mfgr Received2011-04-25
Date Added to Maude2011-05-24
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 FDA0
Event Location0
Manufacturer ContactMR. ORLANDO TADEO, JR.
Manufacturer Street1717 W COLLINS AVE
Manufacturer CityORANGE CA 92867
Manufacturer CountryUS
Manufacturer Postal92867
Manufacturer Phone7145167419
Manufacturer G1ORMCO CORPORATION
Manufacturer Street1332 SOUTH LONE HILL AVENUE
Manufacturer CityGLENDORA CA 91740
Manufacturer CountryUS
Manufacturer Postal Code91740
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDAMON CLEAR
Generic NameORTHODONTIC PLASTIC BRACKET
Product CodeNJM
Date Received2011-05-20
OperatorOTHER
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerORMCO CORPORATION
Manufacturer Address1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-05-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.