Catalog Number V041079000000 |
Device Problems
Break (1069); Device Damaged by Another Device (2915)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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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.Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply (b)(4).The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
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Event Description
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In this event it was reported that a contra angle 6:1 for vdw.Gold/silver was involved in a file breakage; no injury resulted.
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Manufacturer Narrative
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Contra angle (b)(4) (plain bearing, overhead drive and pressure cover) defective.
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Manufacturer Narrative
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Please note, the incorrect manufacturer (g1) was inadvertently reported in the initial submission.See corrected manufacturer in (g1) of this report.
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Search Alerts/Recalls
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