The reported adverse event is associated with a returned device; however, insufficient clinical information was provided by the clinic which made it impossible to establish the root cause of the issue.Hence, no specific device analysis is deemed necessary at this time.Should more information be made available at a later date, the decision could be reassessed.This report is submitted on oct 12, 2023.
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Per the clinic, the patient was placed under general anesthesia on (b)(6) 2023, in order to explant the implant and remove the abutment due to unknown medical reason.It is unknown if there are plans to re-implant the patient with a new device as of the date of this report.
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