Device Problem
Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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There was a total of four (4) malfunctioned units/events associated with engagement issues the reported abutment.A review of the device history record is performed for any reported event with a valid and confirmed lot number.No non-conformances were noted.Therefore, the conclusion of the device records review concluded the product was manufactured to specifications.1 of the 4 events did not have product returned for evaluation.Therefore, no conclusion can be drawn to nature of the reported event.2 of the 4 events are pending investigation.Product has been returned but no evaluated as of yet.Therefore, the conclusion is not yet available.1 of the 4 events had product returned.The evaluation of the product determined the engagement issue was caused by the end user resulting in a misuse.(b)(4).
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Event Description
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This report summarizes four (4) malfunction events.A review of the events involved abutments experiencing engagement issues.The report(s) were received from various sources.Zero (0) patient adverse events were reported.No information regarding patient demographics have been provided.
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Manufacturer Narrative
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There was a total of four (4) malfunctioned units/events associated with engagement issues the reported abutment.A review of the device history record is performed for any reported event with a valid and confirmed lot number.No nonconformances were noted.Therefore, the conclusion of the device records review concluded the product was manufactured to specifications.1 of the 4 events did not have product returned for evaluation.Therefore, no conclusion can be drawn to nature of the reported event.2 of the 4 events are pending investigation.Product has been returned but no evaluated as of yet.Therefore, the conclusion is not yet available.1 of the 4 events had product returned.The evaluation of the product determined the engagement issue was caused by the end user resulting in a misuse.Health effect- impact code (h6): the health impact associated with the reported problem is rarely provided during the collection of information for the reported malfunction.Therefore, code 4648 is being used in h6 - health effect - impact code.Component code (h6): code 4756 within the component code section of h6 is being used because no other code within annex g is compatible with pro codes nha or ndp.Item number - pgmu1 ( udi: (b)(4)); pymu172 (qty 2) ( udi: (b)(4)).Unknown, item.
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Event Description
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This report summarizes four (4) malfunction events.A review of the events involved abutments experiencing engagement issues.The report(s) were received from various sources.Zero (0) patient adverse events were reported.No information regarding patient demographics have been provided.
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Search Alerts/Recalls
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