DAMON COPPER NITI WIRE 205-1902

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 2009-10-15 for DAMON COPPER NITI WIRE 205-1902 manufactured by Ormco Corporation.

Event Text Entries

[1184157] On september 16, 2009, a doctor informed ormco corporation that he had damon cuniti wire breakages.
Patient Sequence No: 1, Text Type: D, B5


[8399966] There are no reported injuries associated with this incident. However, due to the prior submission of a reportable incident on the damon copper niti wire on february 6, 2008 (mdr #2016150-2008-00001: malfunction which required intervention to prevent permanent impairment/damage) this incident is reportable. This incident falls under the fda presumption this type of malfunction is likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2016150-2009-00083
MDR Report Key1507002
Report Source05
Date Received2009-10-15
Date of Report2009-09-16
Date Mfgr Received2009-09-16
Date Added to Maude2010-02-24
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 COPPER NITI WIRE
Generic NameWIRE, ORTHODONTIC
Product CodeDZC
Date Received2009-10-15
Catalog Number205-1902
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 2009-10-15

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