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Catalog Number 37504 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Event Description
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According to available information, a simplant surgiguide was used for planning and placing four (4) implants in the mandible of a patient.The preparation of the implant bed for 3 implants was successfully performed, while a fenestration of the lingual bone plate occurred when preparing the osteotomy for the implant in region 44.The investigation of the returned guide revealed that it was mirroring the situation as planned with the simplant software and provided the same position on the bone model as in the planning.The implant in region 44 was not placed and the surgical treatment was not completed as indicated.
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Manufacturer Narrative
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Therefore, because surgery could not be completed, this event is reportable per 21 cfr part 803.
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Search Alerts/Recalls
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