DAMON UTILITY OPENING/ CLOSING PLIER 866-4006

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 2006-08-15 for DAMON UTILITY OPENING/ CLOSING PLIER 866-4006 manufactured by Ormco Corp..

Event Text Entries

[520105] In 2006, a doctor informed ormco corporation that a damon opening/closing plier had a broken tip insert, braze failure.
Patient Sequence No: 1, Text Type: D, B5


[7798474] There were no reported injuries associated with this incident. However, due to the prior submission of a reportable incident on the damon plier in 2005 (mdr #2016150-2005-00001: malfunction which led to a serious injury), this incident is reportable. This incident falls under the fda presumption that 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 Number2016150-2006-00046
MDR Report Key773573
Report Source05
Date Received2006-08-15
Date of Report2006-07-21
Date of Event2006-07-01
Date Mfgr Received2006-07-21
Device Manufacturer Date2004-04-01
Date Added to Maude2006-10-27
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 FDA3
Event Location0
Manufacturer ContactWENDY URTEL
Manufacturer Street100 BAYVIEW CIRCLE SUITE 6000
Manufacturer CityNEWPORT BEACH CA 92660
Manufacturer CountryUS
Manufacturer Postal92660
Manufacturer Phone9492558767
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 UTILITY OPENING/ CLOSING PLIER
Generic NamePLIER, ORTHODONTIC
Product CodeJEX
Date Received2006-08-15
Returned To Mfg2006-07-21
Model NumberNA
Catalog Number866-4006
Lot Number04D36
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key761357
ManufacturerORMCO CORP.
Manufacturer Address1332 SOUTH LONE HILL AVE. GLENDORA CA 91740 US
Baseline Brand NameDAMON UTILITY OPENING/CLOSING PLIER
Baseline Generic NameORTHODONTIC PLIER
Baseline Model NoNA
Baseline Catalog No866-4006
Baseline IDNA
Baseline Device FamilyPLIER, ORTHODONTIC
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2006-08-15

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