Method: the copios pericardium was not returned to rti for evaluation.A re-review of the manufacturing and internal records, sterilization run reports, environmental monitoring results, quality control/assurance review and release, and review of the complaints for related complaints associated with the lot were performed.Results: no deviations were noted during the processing for lot# nz14380129 that affected the release of serial id (b)(4).The graft underwent a validated sterilization methodology; tutoplast® which includes terminal sterilization by (b)(4) after packaging.To date, rti has distributed (b)(4) copios pericardium membranes from the lot without related complaints.Environmental data and records generated during and around the time of processing were acceptable.Conclusion: no deviations were noted during records for lot # nz14380129.Serial id (b)(4) was manufactured to specification and met all requirements and release criteria at the time of distribution.There are no related complaints associated with copios pericardium membranes distributed from the lot.Based on the records re-review and the information provided, this event is unlikely related to the xenograft implant.
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Rti surgical, inc (rti) and tutogen medical (b)(4), a wholly owned subsidiary of rti, received a complaint on 09/28/16 reporting that copios pericardium membrane was utilized in a dental procedure with 3 puros allografts (2 cancellous particles and 1 patientenindividuller block).The patient experienced infection, suture dehiscence and bone loss.
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