Per the clinic, the explant on (b)(6) 2023, was performed under general anesthesia.The reported adverse event is associated with a returned device; however, the provided clinical information was reviewed by the manufacturer and no specific device analysis is deemed necessary at this time.Previous product examinations have not showed any relationship between a product geometrical deviation and the reported clinical complication.Additionally, there are no indications that a product failure has contributed to the reported issue.Transient pain is a known medical complication where most cases can be resolved with clinical case management.Known reasons for cause of pain are abnormal skin sensitivity, earlier trauma to the implanted area, lack of adequate bone quality or other generalized diseases.It might also be due to a loose implant magnet, causing pain around the implanted area when using the baha sound processor.This report is submitted on september 21, 2023.
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