3M UNITEK TRANSBOND PLUS SELF ETCHING PRIMER 712-090

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-22 for 3M UNITEK TRANSBOND PLUS SELF ETCHING PRIMER 712-090 manufactured by 3m Unitek Corporation.

Event Text Entries

[112096039] This event may be related to the previously compromised restoration of the tooth. Since this event involved two medical devices, two manufacturer reports are being submitted. This report (2020467-2018-00004) represents the second medical device, and 2020467-2018-00003 represents the first device.
Patient Sequence No: 1, Text Type: N, H10


[112096040] On (b)(6) 2018, 3m was notified that a male patient, approximately (b)(6), had a large buccal filling break off from a previously restored upper pre-molar tooth of a 3m apc ii clarity advanced ceramic bracket. The break was reported to be down to dentin. The bracket had been in place for approximately 18 months. The orthodontist reported that the large filling/restoration on the tooth did not look normal. Other products used when the bracket was initially bonded included a non-3m brand etchant. In addition, although the brand of the primer or catalog number was not disclosed by the reporting facility, based upon a description of the product and sales history, it is suspected that 3m transbond plus self etching primer was also potentially used.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020467-2018-00004
MDR Report Key7631090
Report SourceHEALTH PROFESSIONAL
Date Received2018-06-22
Date of Report2018-06-22
Date of Event2018-05-31
Date Mfgr Received2018-06-01
Date Added to Maude2018-06-22
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 Location3
Manufacturer ContactMARK BURVILLE
Manufacturer Street2510 CONWAY AVENUE
Manufacturer CityST. PAUL,
Manufacturer G13M UNITEK
Manufacturer Street2724 SOUTH PECK RD.
Manufacturer CityMONROVIA CA 910165097
Manufacturer CountryUS
Manufacturer Postal Code910165097
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3M UNITEK TRANSBOND PLUS SELF ETCHING PRIMER
Generic NameAGENT, TOOTH BONDING, RESIN
Product CodeKLE
Date Received2018-06-22
Catalog Number712-090
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer3M UNITEK CORPORATION
Manufacturer Address2724 SOUTH PECK RD. MONROVIA CA 910165097 US 910165097


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-06-22

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