Catalog Number 8035-72 |
Device Problem
Failure to Osseointegrate (1863)
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Patient Problems
Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Osteopenia/ Osteoporosis (2651)
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Event Date 03/10/2021 |
Event Type
Injury
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Event Description
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Per complaint (b)(4), after clinical procedure, patient experienced loss of implant to osseointegrate.
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Manufacturer Narrative
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Patient's age, weight were not provided.If the requested information becomes available, a supplementary report will be submitted.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.
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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.Patient age and sex are unknown.
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Search Alerts/Recalls
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