APC CLARITY METAL-REINFORCED CERAMIC BRACKET 6500-609

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 2002-07-22 for APC CLARITY METAL-REINFORCED CERAMIC BRACKET 6500-609 manufactured by 3m Unitek.

Event Text Entries

[19779271] Orthodontist reported that during the debonding of an apc clarity ceramic bracket, tooth dentin was exposed when a piece of enamel (1. 5mm in diameter and 1. 5 mm in depth) was removed from a pt's upper left second bicuspid. Orthodontist stated that the tooth was in good condition prior to orthodontic treatment, that he used the correct technique and instrument for debonding the bracket. However, a remnant of the bracket base was left on the tooth, and orthodontist reported that he used a straight cutter to remove the bracket remnant. The instructions-for-use direct the orthodontist that "if a bracket fractures during treatment or debonding, use a diamond burr to remove the ceramic fragments". The tooth was repaired with composite material.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020467-2002-00009
MDR Report Key406501
Report Source05
Date Received2002-07-22
Date of Report2002-06-24
Date of Event2002-06-21
Date Mfgr Received2002-06-24
Date Added to Maude2002-07-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
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 CLARITY METAL-REINFORCED CERAMIC BRACKET
Generic NameORTHODONTIC CERAMIC BRACKET
Product CodeDYW
Date Received2002-07-22
Model NumberNA
Catalog Number6500-609
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key395488
Manufacturer3M UNITEK
Manufacturer Address2724 SOUTH PECK RD. MONROVIA CA 91016 US
Baseline Brand NameAPC CLARITY METAL-REINFORCED CERAMIC BRACKET
Baseline Generic NameORTHODONTIC ADHESIVE AND CERAMIC BRACKET
Baseline Model NoNA
Baseline Catalog No6500-609
Baseline Device FamilyAPC CLARITY METAL-REINFORCED CERAMIC BRACKET
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]12
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK911241
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2002-07-22

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