APC II CLARITY METAL-REINFORCED CERAMIC BRACKET 6700-737

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 2005-01-24 for APC II CLARITY METAL-REINFORCED CERAMIC BRACKET 6700-737 manufactured by 3m Unitek.

Event Text Entries

[393434] Orthodontist stated that during the debonding of clarity ceramic brackets, all of the brackets debonded easily except for the bracket on pt's upper left second bicuspid tooth. After debonding, orthodontist observed that a piece of enamel down-to-dentin had fractured during the debonding. Orthodontist stated the pt's tooth has been repaired with composite.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020467-2005-00002
MDR Report Key568081
Report Source05
Date Received2005-01-24
Date of Report2005-01-12
Date of Event2004-12-15
Date Mfgr Received2005-01-12
Date Added to Maude2005-01-28
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 ContactMARLYN SCHEFF
Manufacturer Street2724 SOUTH PECK ROAD
Manufacturer CityMONROVIA CA 91016
Manufacturer CountryUS
Manufacturer Postal91016
Manufacturer Phone6265744496
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAPC II CLARITY METAL-REINFORCED CERAMIC BRACKET
Generic NameORTHODONTIC BRACKET
Product CodeDYW
Date Received2005-01-24
Model NumberNA
Catalog Number6700-737
Lot NumberUK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key557909
Manufacturer3M UNITEK
Manufacturer Address2724 SOUTH PECK RD. MONROVIA CA 91016 US
Baseline Brand NameAPC II CLARITY METAL-REINFORCED CERAMIC BRACKET
Baseline Generic NameORTHODONTIC ADHESIVE & CERAMIC BRACKET
Baseline Model NoNA
Baseline Catalog No6700-737
Baseline Device FamilyAPC II CLARITY METAL-REINFORCED CERAMIC BRACKET
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]12
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK911271
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2005-01-24

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