Model Number CI632 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Fluid Discharge (2686)
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Event Type
Injury
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Manufacturer Narrative
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This report is submitted on january 9, 2020.
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Event Description
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Per the surgeon, the patient experienced an infection at the implant site that was treated with oral antibiotics.The implant remains in-situ.
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Manufacturer Narrative
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Per the clinic, the skin was debrided using silver nitrate.This report is submitted on march 31, 2020.
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Manufacturer Narrative
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Per the clinic, it was reported that the patient underwent wound revision on (b)(6) 2020, due to pain, swelling and blood drainage at the implant site.The patient has been treated with oral steroids and antibiotics.This report is submitted july, 2020.
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Manufacturer Narrative
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It was reported that the device was explanted on (b)(6) 2020.This report is submitted on 6 october 2020.
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Search Alerts/Recalls
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