DAMON CLEAR 497-6471

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 2010-11-20 for DAMON CLEAR 497-6471 manufactured by Ormco Corporation.

Event Text Entries

[1811774] On october 20, 2010, 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


[8899094] The doctor's office reported that the debonding of a damon clear bracket caused enamel delamination when a doctor removed it for repositioning. The tooth was repaired and re-prepped and a new damon clear bracket was bonded. The patient is doing fine. The doctor stated that when the bracket was initially placed, he applied ortho solo plus to both the tooth and the bracket. This goes against the instructions for use for ortho solo plus which states that it should be applied to only the tooth, as applying excess primer beyond the instructed usage will increase bond strength and could subsequently result in enamel damage upon debonding. A visual inspection of the returned bracket indicated that an excess amount of adhesive was applied which also increases bonding forces and can also result in enamel damage upon debonding. The visual inspection also indicated that the bracket was placed very close to the gingiva. The location of the bracket may have limited the access of the debonding instrument, resulting in poor positioning of the debonding tool and subsequent enamel damage. The results of the investigation indicate that the cause for the enamel damage was due user error and not to a product failure.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2016150-2010-00189
MDR Report Key1903937
Report Source05
Date Received2010-11-20
Date of Report2010-10-20
Date Mfgr Received2010-10-20
Date Added to Maude2010-11-22
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 Received2010-11-20
Catalog Number497-6471
OperatorOTHER
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerORMCO CORPORATION
Manufacturer Address1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2010-11-20

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