Model Number CI422 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Necrosis Of Flap Tissue (1972); Ulcer (2274); Patient Problem/Medical Problem (2688)
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Event Type
Injury
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Manufacturer Narrative
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This report is submitted on 01 june 2020.
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Event Description
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Per the clinic, the patient experienced an ulcer at implant site resulting in exposure of implant.Subsequently the device was explanted (date not reported) and the patient was re-implanted with a new device during the same surgery.
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Manufacturer Narrative
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There was reported necrosis at the extruded implant site.The device analysis report is attached.This report is submitted on august 7, 2020.Attachment: [01425 device analysis report.Pdf].
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Event Description
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There was reported necrosis at the extruded implant site.
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Search Alerts/Recalls
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