Catalog Number 0502555100 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/04/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.(b)(4).
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Event Description
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It was reported that the product broke.The broken pieces were retrieved and the procedure was completed successfully.
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: broke off in patient was retrieved no harm the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be excessive force, or rotational force with the jaw under load.The reported failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.(b)(4).
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Event Description
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It was reported that the product broke.The broken pieces were retrieved and the procedure was completed successfully.
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Search Alerts/Recalls
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