3M ESPE DENTAL PRODUCTS LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC; MATERIAL, TOOTH SHADE, RESIN
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Catalog Number 2914A2-LT |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Code Available (3191)
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Event Date 04/07/2016 |
Event Type
Injury
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Manufacturer Narrative
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Based on the available information, it is not known what role, if any, lava ultimate played in the reported patient outcome.Other factors, such as prior tooth history or other dental treatments, may have played a role in the need for tooth extraction.
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Event Description
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This case was identified through post-market surveillance activities.Records provided by the dental professional indicated that this female patient (age or date-of-birth were not provided) required extraction of tooth #19.This tooth had received a lava ultimate crown on (b)(6) 2013, because the prior restoration on the tooth had open margins.In addition, this tooth had undergone root canal treatment at some prior point.On (b)(6) 2013, the lava ultimate crown was adjusted because of sensitivity.On (b)(6) 2015, the patient reported a dull ache in the area around this tooth; notes indicate that the dentist believed this was due to soft tissue issues because of the pre-existing root canal.On (b)(6) 2016, the crown was noted as loose; it was removed, decay was identified and the tooth was extracted.
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