The implant was not returned for evaluation.Therefore, a comprehensive records re-review was conducted.There were no departures noted that would negatively impact the xenograft implants manufactured from lot pd17210001.Manufacturing records review indicated that serial id (b)(4) met all specifications and release criteria prior to distribution.Rti/tmi has manufactured and distributed a total of 24 xenograft implants from the lot without related complaints.Porcine dermis xenograft implants udnergo a validated sterilization method: tutoplast®, which includes terminal sterilization by gamma irradiation after packaging.To date, our investigation indicates that the reported complications are more likely associated with one or more extrinsic factors, rather than an intrinsic property of fortiva porcine dermis xenograft.
|
Rti surgical, inc (rti) and tutogen medical (b)(4))tmi, a wholly owned subsidiary of rti, received a complaint which indicated that a patient, enrolled in the fortiva appear trial, underwent nipple sparing mastectomy of the left breast with implantation of a fortiva perforated porcine dermis graft and a silicone breast implant on (b)(6) 2019.The patient received antibiotics during surgery and two drains were left in place in the axila.On (b)(6) 2019, she developed necrosis of the left breast bar area which was considered to be procedure related and not related to the fortiva implant.The drains were removed on (b)(6) 2019 and the patient was discharged.On (b)(6) 2019, the patient underwent necrosis ablation and on (b)(6) 2019, a third of the fortiva graft was removed.Upon follow up on (b)(6) 2019, good wound healing was noted.A seroma was seen on ultrasound which was drained, revealing a serous fluid.The patient is doing well.To date, no additional information has been received.
|