Catalog Number UNK ATIS EV ABUTMENT |
Device Problem
Fracture (1260)
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Patient Problems
Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Pocket Erosion (2013)
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Event Date 09/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.Section was done based on the information provided by the initial reporter and our long-time experience in the investigation of similar complaints.Product return is requested and product will be evaluated after receipt.In case any new or additional information will be gained from this investigation a follow-up report will be sent.Trend is tracked and monitored.
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Event Description
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It was reported that a patient experienced a dental implant loss.
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Manufacturer Narrative
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The optical investigation showed that the implant is not fractured but was removed due to the fracture of a screw or one-piece abutment.Corrected product information, lot number and concomitant product in this report.This report is to also correct the following codes: component code: add 568; type of investigation: add 10 and 4116; investigation findings: remove 3243.
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Search Alerts/Recalls
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