Model Number ASKU |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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Per the clinic, the patient experienced skin overgrowth on the abutment, and was treated with a topical steroid cream (specific duration not reported).The implanted device remains.
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Manufacturer Narrative
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This report is submitted on 20 may 2021.
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Event Description
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Per the clinic, it was reported that the patient underwent revision surgery on (b)(6) 2021, in order to convert the patient to a transcutaneous osia implant system.During the procedure, the abutment was removed and an implant was placed on the internal fixture.
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Search Alerts/Recalls
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