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.
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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.
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