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Catalog Number PTGRF121 |
Device Problem
Material Too Rigid or Stiff (1544)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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As a result of this error, the files lack flexibility, which can lead to file separation.Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.
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Event Description
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It was reported that a protaper gold file was not bending like usual.The doctor stated the files felt more like protaper universal files.However, upon investigation on april 6, 2018, it was found that the files were in fact protaper gold files, but they were not heat treated to specification.
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Search Alerts/Recalls
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