Model Number CI-1500-04 |
Device Problems
Expulsion (2933); Material Protrusion/Extrusion (2979)
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Patient Problems
Erosion (1750); Inflammation (1932)
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Event Date 07/08/2022 |
Event Type
Injury
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Manufacturer Narrative
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Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Event Description
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The recipient reportedly experienced inflammation above implant site, device extrusion, and retention issues.The recipient ceased device use for one year.The recipient's device was reportedly explanted.The recipient is in the process of healing.Reimplantation will be considered once healing is complete.
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Manufacturer Narrative
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The medical issue that led to revision surgery was reportedly not device related.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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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 recipient has not provided consent despite several requests to the recipient¿s medical institution to obtain and provide the consent.As a result, no conclusion can be drawn at this time.If the consent is received at a later date, the issue will be re-opened and the results of the analysis will be reported.The device remains intact in a locked vault at ab, llc until consent is obtained.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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