Catalog Number SD2.3C |
Device Problem
Fracture (1260)
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Patient Problem
Failure of Implant (1924)
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Event Date 08/17/2021 |
Event Type
Injury
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Manufacturer Narrative
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Patient identifier, other relevant history, including preexisting medical conditions, implant date and explant date were not provided.If the requested information becomes available, a supplementary report will be submitted.Patient age is unknown.Lot information unknown.If additional information becomes available a supplementary report will be submitted.Udi number is not applicable.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, broken or fractured component.
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Manufacturer Narrative
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Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d9 for device return date, g1 for follow-up report submitter, g3 for awareness date and g6 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.
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Search Alerts/Recalls
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