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Catalog Number 37501 |
Device Problems
Unstable (1667); Malposition of Device (2616)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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This event is reportable per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
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Event Description
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The clinician used a simplant safe guide, for an azento order, to create the osteotomy for implant on tooth position 13 in combination with the astra tech guided surgery kit.The clinician noticed that there was no primary stability for the implant when torquing the implant.The implant site was regrafted and a new order will be placed in three months after healing.
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Manufacturer Narrative
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Guide received broken, unable to investigate.A dhr review was conducted with no discrepancies noted.
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Search Alerts/Recalls
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