Per the clinic, the patient developed an infection at the implant site.Subsequently, the abutment was removed; however, the implanted fixture remains insitu.There are plans to resume use of the device once the site has healed.
|
Additional information was received: per the clinic, the abutment removal was conducted under a general anaesthetic on october 20, 2017, where there was a skin revision.The site has reportedly since healed and the patient has resumed use of the device.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.Adverse skin reactions around the baha abutment, ranging from slight redness to infected tissue, are common complications with baha implants, and can occur at any time following implantation.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.
|