On (b)(6) 2018, osteomed was notified of an incident concerning an abscess that occurred in a patient with osteomed implants.Per the sales representative, the patient received multiple implants as part of a lefort i osteotomy procedure performed on (b)(6) 2018.Almost one (1) month following the procedure, the patient experienced right cheek swelling.On (b)(6) 2018, the area of the surgery was opened to locate the abscess.The area was allowed to drain.Following drainage, the area was irrigated.A culture was taken and sent for testing.The results did not identify any organisms.
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The root cause of the abscess could not be determined.The device was not explanted.Per the operative report provided, the abscess was on the inside of the right cheek.The surgery to drain the abscess occurred on (b)(6)2018, which is nearly a month after the implant surgery on 03/19/18.The report states the abscess cavity is close to the skin surface and that the culture taken was "suggestive of usual skin flora" with "no clinically significant organisms present".As of the mid-may, the patient has fully healed (from the abscess).The review of the device history record did not identify any non-conformance's associated with product release.The review of capas and ncrs did not identify any internal investigations for this device.This is the first complaint ever received for this device.The risk of patient harm with a major infection is covered in the fmea.It has a severity rating of 4 (critical) and an overall risk rating of "low".The orthognathic system ifu warns the user that osteomed single use devices cannot be reused and/or reprocessed, due to an increased risk of contamination.It also warns of the potential risks of cross infection/contamination associated with using inadequately cleaned and sterilized devices.It states as a contraindication anyone who has a case of active or suspected infection, or patients who are immunocompromised, or in patients previously sensitized to titanium, or in patients with certain metabolic diseases.It also states that it is recommended to use osteomed products in a sterile environment.Finally, it states that these plates, screws, and instruments are supplied non-sterile and must be sterilized prior to use.From all indications, it appears that the abscess was unrelated to implanted device.Therefore, the device was not found to be defective.This issue will be monitored through routine trending.
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