Per the surgeon, it was reported that the patient underwent explant surgery on
(b)(6) 2023, in order to convert the patient to a transcutaneous osia implant system.During the procedure, the internal magnet was removed.Additional information has been requested but has not been made available as of the date of this report.
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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.Elective removal of an implant is a procedure which requires medical/surgical intervention.The report frequency for these complications is being monitored under cbas complaint and medical device reporting data monitoring plan and the status is updated on a monthly basis.This event is added to this monitoring.This report is submitted on december 06, 2023.
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