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Device Problem
Insufficient Information (3190)
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Patient Problem
Missing Value Reason (3192)
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Event Date 02/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Specific patient information with regards to age, gender, weight was not provided.The patients required a re-treatment of the root canal.The product was not returned and no lot number was provided; therefore, no evaluation can be conducted.
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Event Description
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A doctor alleged that while performing a resilon retreatment several findings were noted.The findings were indicated as black pigmentation, soft resilon material, necrotic smell, lesions, and infected.
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Search Alerts/Recalls
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