Model Number 304310 |
Device Problems
Failure to Osseointegrate (1863); Implant, removal of (2320); Implant Mobility NOS (Not otherwise specified) (2645)
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Patient Problem
Failure of Implant (1924)
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Event Date 01/01/2015 |
Event Type
Injury
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Manufacturer Narrative
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Records indicate that the implant met the specifications and were approved for product release.Ace surgical has not been issued the failed implant.Physical analysis cannot be performed.This implant loss suggests that the source of the problem was likely to stem from procedural errors and/or the lack of osseointegration.The loss of integration or the non-integration of an endosseous dental implant is a known inherent risk of the procedure as described in this product's instructions for use.
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Event Description
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After removing cover screw, no osseointegration was noticed.X-rays reportedly showed signs of bone loss.Bone quality at time of implant failure was described as porous.
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Search Alerts/Recalls
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