Catalog Number UNK MAILLEFER |
Device Problems
Break (1069); Difficult to Remove (1528)
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Patient Problems
Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.The device was not returned for evaluation.However, the lot number was provided and retained-product testing and/or dhr review are planned.The results will be submitted as they become available.
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Event Description
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In this event it has been reported that protaper universal file 25mm-s1 was broken during use.The broken part can not be retrieved and filled in the canal.There is no patient injury occurred.
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Manufacturer Narrative
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Involved products that broke during use were not returned and cannot be analyzed.Moreover, no unused file is available for evaluation.The provided batch number (batch #14772997) has no corresponding in our system and is likely erroneous (8 digits; standard maillefer batches only have 7 digits).The right batch number is unknown, dhr cannot be reviewed.Root causes are not identified.We will track this kind of event and monitor the trend.
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Search Alerts/Recalls
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