Model Number CI622 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Bacterial Infection (1735); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/30/2022 |
Event Type
Injury
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Event Description
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Per the clinic, the device was explanted on (b)(6) 2022, due to unknown medical reasons.Additional information has been requested but has not been made available as of the date of this report.
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Manufacturer Narrative
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Device analysis report is attached.This report is submitted on september 28, 2022.
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Manufacturer Narrative
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Per the clinic, the patient experienced an infection at the implant site (specific date not reported).Additional information has been requested but has not been made available as of the date of this report.This report is submitted on november 09, 2022.
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Manufacturer Narrative
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Per the clinic, the patient was treated with oral, iv and topical antibiotics (specific date and duration not reported).This report is submitted on october 27, 2023.
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Search Alerts/Recalls
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