Per the implanting physician, the patient is doing well.
Of the 197 released allografts, there have been no other reports of adverse reactions to date. Non-pathogens (cns and propionibacterium acnes) were isolated from 4 procurement cultures. (b)(6), the supplier of the dbm component, reported that a total of 185 cultures were performed throughout aseptic recovery and processing of the two donors involved in this complaint.Ĥ7 out of 51 procurement cultures and all 134 final processing cultures (including 10% destructive testing cultures) were negative. The surgeon has stated in writing that he does not believe the infection was connected to the product implanted. Vancomycin and had incision and drainage of wound x2. It was reported that the patient had intra-operative cultures done, both deep and superficial.ĭeep was (b)(6) and no growth on gram stain. On (b)(6) 2011, lifecell received culture results from (b)(6) that were forwarded to (b)(6)from the complainant. Lifecell will file follow-up report if additional information becomes available.
Review of the device history records resulted in no remarkable findings.Īs of (b)(4) 2011, all 81 devices from the affected lots were distributed with no issues or other complaints reported to lifecell against these lots.īased on internal investigation, the device met release criteria for finished product at the time of release.ĭue to limited information received, this event is being reported. Query of lifecell complaint system for any issues or other complaints reported against devices distributed from these lots. Review of the device history records for lots b11e09a (manufacture date:, exp ) and b11a31a (manufacture date:, exp. It was reported that culture was taken but lifecell has not been able to obtain the culture results. The patient developed post-operative infection that was treated with antibiotics and debridement of wound. On (b)(6) 2011 the patient had bone graft and 2 allograft injections. LIFECELL CORPORATION ALLOCRAFT DBM FILLER, BONE VOID, PRODUCT CODE: MBP
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