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Catalog Number MG-STN3 |
Device Problems
Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Failure of Implant (1924)
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Event Type
malfunction
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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.The device was not evaluated because the issue is a known inherent risk of the device.We will continue to track and monitor the trend.
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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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Event Description
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Treatment was stopped because of mguide did not fit in patient's mouth.
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Manufacturer Narrative
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Investigation summary: we received only the guide.No model.Fit issue cannot be investigated.Dhr was conducted, no issues found.Model and guide were sent to us as stl - files by the customer (pro - user).Based on customers data (customer designed the guide).No issues found.Model for the remake differs from original model.Based on this customers data, customer redesigned the guide.Please disregard the initial report - this is not a dental implant loss.This was mistakenly entered.Correcting describe event or problem from (b5) "it was reported that a patient experienced a dental implant loss." to corrected statement of : treatment was stopped because of mguide did not fit in patient's mouth.This is to correct and remove the codes that were initially reported - removing codes for: medical device problem code - 1158, type of investigation code - 4112.The corrected and/or additional codes for this event are: medical device problem code - 2993, type of investigation code - 10 + 3331, investigation findings code - 213, investigation conclusions code - 67.
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Search Alerts/Recalls
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