Additional information was requested regarding the product details; however, were not made available as of the date of this report.This report is submitted on march 5, 2018, (b)(4).
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Per the clinic, it was reported that the patient experienced recurrent skin infections and overgrowth at the implant site.The first occurrence, on (b)(6) 2015, was treated with oral antibiotics.The second occurrence on (b)(6) 2016, the patient presented with a small abscess.Cultures returned staphylococcus aureus and streptococcal, therefore the patient was treated with oral and topical antibiotics.On (b)(6) 2017, the patient presented to the ed with an infection and drainage at the implant site.Subsequently, the patient was treated with oral and topical antibiotics.On (b)(6) 2017, the patient was seen for follow up and treated with an additional course of oral antibiotics.On (b)(6) 2018, the patient's abutment was removed.Cultures returned multiple organisms, and the patient was treated once more with oral antibiotics.The patient has discontinued use of the device; however, the fixture remains insitu.
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