Model Number CI-1601-05 |
Device Problems
Expulsion (2933); Material Protrusion/Extrusion (2979)
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Patient Problems
Erosion (1750); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/21/2022 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced thinning of the skin flap and device extrusion following cancer treatment.The recipient's device was explanted.The recipient will be reimplanted at a later date.
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Manufacturer Narrative
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The recipient reportedly underwent a skin flap repair with plastic surgery and is healing well.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The explanted device is presumed lost and will not return for analysis.A review of the device history record was completed and no anomalies were noted.No further details will be provided.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Search Alerts/Recalls
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