The reported adverse 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.Implant loss with baha implants can occur at any time following implantation.Known reasons for implant loss include lack of adequate bone quality/quantity, trauma, infection, generalised diseases and surgical complication.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 march 26, 2020.
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Per the clinic, it was reported that the patient experienced a lack of osseointegration resulting in fixture loss due to compromised bone and localised site granulation.The patient was treated with topical medication following the fixture loss (type not reported).It is unknown whether there are plans to reimplant the patient, as of the date of this report.
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