Rti surgical, inc.(rti) and tutogen medical (b)(4), a wholly owned subsidiary of rti received a complaint on (b)(6) 2015 reporting a tutomesh graft was utilized in a left thoracic wall replacement procedure on (b)(6) 2015.On an unknown date, the graft ruptured and the scapula slipped into the thorax.The patient underwent a revision procedure on (b)(6) 2015.The complaint notification indicated the patient's medical history was significant for plasmocytome of the left thoracic wall.
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Method: graft was not returned to rti for evaluation, therefore a re-review was performed of the manufacturing records, sterilization run reports, environmental monitoring results, quality control / assurance reviews and release, and the complaint database for related complaints associated with the lot.Results: no deviations were noted during processing for lot# nz12140003.The graft underwent a validated sterilization methodology; tutoplast which includes terminal sterilization by gamma irradiation after packaging.To date, rti has distributed 5 xenografts from the lot.There is 1 related complaint associated with the physician, surgery type, and lot.Environmental data and records generated during and around the time of processing for lot# nz12140003 were acceptable.Conclusion: given that no deviations were noted in records re-view, graft id (b)(4) was manufactured to specification prior to distribution; the complex nature of the surgical procedure along with possible initiation of post-operative therapy; and the timeline from the initial surgical procedure to the revision procedure was 60 days, it is more plausible that the patient's surgical outcome and complications were associated with a source or event extrinsic to the xenograft implant.
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