Catalog Number HT1.25 |
Device Problem
Material Deformation (2976)
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Patient Problem
Failure of Implant (1924)
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Event Date 04/18/2022 |
Event Type
Injury
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Manufacturer Narrative
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Implant date and explant date are not applicable since the product was never placed and not removed.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.
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Event Description
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Per complaint (b)(4), during clinical procedure, product fractured.
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Manufacturer Narrative
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Follow-up submitted to report device evaluation.
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Search Alerts/Recalls
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