MULTI-CURE GLASS LONOMER BAND CEMENT 712-050

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 2001-09-24 for MULTI-CURE GLASS LONOMER BAND CEMENT 712-050 manufactured by 3m Unitek.

Event Text Entries

[17417242] Orthodontist reported that they had used multi-cure glass lonomer orthodontic band cement to bond stainless steel crowns to patient's molar teeth and then to attach a herbst appliance to the crown. Upon debonding the crown on tooth #30 (lower right first molar), one of the cusps was removed which resulted in exposed dentin. The tooth was repaired with sealant.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020467-2001-00006
MDR Report Key353294
Report Source05
Date Received2001-09-24
Date of Report2001-08-31
Date of Event2001-08-23
Date Mfgr Received2001-08-31
Date Added to Maude2001-09-28
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 NameMULTI-CURE GLASS LONOMER BAND CEMENT
Generic NameORTHODONTIC BAND CEMENT
Product CodeDYH
Date Received2001-09-24
Model NumberNA
Catalog Number712-050
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key342534
Manufacturer3M UNITEK
Manufacturer Address2724 SOUTH PECK ROAD MONROVIA CA 91016 US
Baseline Brand NameMULTI-CURE GI CEMEMT KIT
Baseline Generic NameGLASS IONOMER BAND CEM
Baseline Model No712-050
Baseline Catalog No712-050
Baseline IDNONE
Baseline Device FamilyGLASS IONOMER CEMENT/ADHESIVE
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]12
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK950514
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2001-09-24

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