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Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Specific patient information with regards to age, gender, ethnicity, race and weight was not provided.No lot number was provided therefore manufacture date cannot be determined.The product was not returned and no lot number or part number was provided; therefore, no evaluation can be conducted.
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Event Description
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A complainant alleged that when performing a resilon re-treatment the following was noted, breakdown of the resilon material, gooey, soft, and periapical infection.The case was retreated with gentle wave.It was reported that there are no internal fractures and prognosis fair to good.
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Search Alerts/Recalls
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