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Lot Number PD20220002 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Seroma (2069); Impaired Healing (2378); Needle Stick/Puncture (2462); Insufficient Information (4580)
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Event Date 07/22/2021 |
Event Type
Injury
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Manufacturer Narrative
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Unique identifiers were not provided in order to conduct a comprehensive records re-review.If additional information is provided, a follow-up report will be submitted.
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Event Description
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Rti surgical, inc.And tutogen medical gmbh (tmi), a wholly subsidiary of rti surgical, received a complaint as part of the fortiva appear study.The complaint indicated that the patient underwent a surgical procedure, on an unknown date, with implantation of an rti fortiva graft.On (b)(6) 2021, the patient developed an unknown type of adverse event.On (b)(6) 2021, the patient developed a seroma.
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Event Description
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Rti surgical, inc.And tutogen medical gmbh (tmi), a wholly subsidiary of rti surgical, received additional information as part of the fortiva appear trial that indicated the patient underwent a nipple conserving inframammary mastectomy and breast reconstruction date of procedure on (b)(6) 2021.A fortiva® dermal graft and two silicone 515cc implants were implanted.Two drains remained indwelling.The right drain was removed on (b)(6) 2021.The left drain was removed on (b)(6) 2021.On (b)(6) 2021, nine days post-operatively, the patient developed a wound healing disorder in the area of the mamilla, on the right side, at the 9 o'clock position.She also developed a wound healing disorder in the area of the mammilla-areola complex half on the left side.The post-operative complication resulted in prolonged inpatient hospitalization.The event is ongoing.On (b)(6) 2021,14 days post-operatively, the patient developed a major seroma (305 cc's) on the right side.She also developed a minor seroma (60cc's) on the left side.Both seromas were treated via aspiration and have resolved.
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Manufacturer Narrative
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Rti germany conducted a batch documentation review for serial id (b)(6) manufactured from lot pd20220002.One departure from standard operating procedures was noted during the records re-review for the lot.Nc 20 39 075: lower deviation drying temperature.The departure did not affect the quality of the product.Manufacturing records review indicated that serial id (b)(6) was manufactured to specification and met all acceptance / inspection criteria prior to distribution.To date, rti germany has manufactured and distributed 18 fortiva® dermal xenografts from lot pd20220002 without related complaints.It was confirmed that only one fortiva® 1.5mm graft was used for both sides.The fortiva® 1.5mm graft has not been approved to be utilized for breast reconstructions.The implanting of the graft for this case constitutes an off label use.Although implant therapy is highly successful and predictable, it is not without possible early and/or late complications.Seroma formation may also be caused by decreased blood supply at the surgical site, poor soft tissue coverage, weight, infection, poor glycemic control, medications, physical location of the surgical site, and cumulative risk factors increase the likelihood of complications.In general, problems in wound healing can be associated with, e.G.Injuries, surgeries, failure of blood supply to the surgical site, infection or radiation therapy.The patient is a current smoker and has undergone prior chemotherapy treatment.This may affect the blood flow and capillary vessel lumen in the skin at the implantation sites.Also, silicone implants were placed on both sides which could be considered as a confounding factor.It is more plausible that the patient's adverse event was associated with a source or event extrinsic to the xenograft implant.
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Search Alerts/Recalls
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