Manufacturing assessment review: five manufacturing records were reviewed and no related deviations or non conformances were observed for the batch a36012 and part# t44115.Grafton crunch test reports were reviewed (base sterility, sterility, endotoxin, moisture analysis, glycerol content, calcium assay).All tests passed and no deviations or non conformances were observed.Donor file & donor eligibility records: donor eligibility documents were reviewed and no non-conformance was found.The donor charts revealed-no deviations from sop, supplies were in compliance and recovery was performed in time and temperature limits.Hcp's reviews based on donor charts: in their opinion the infections weren¿t caused by tissues as received, processed and distributed by us.Event problem and evaluation codes: neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.If information is provided in the future, a supplemental report will be issued.
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It was reported that the patient underwent scoliosis correction surgery from t6 to s1.Post-op, one month later the implantation of the tissues, the patient suffered due to infection in wound.Patient immune was not compromised and she was not undergoing chemotherapy.Patient went through 24 hour prophylaxis protocol after the initial surgery.The symptoms appeared 10 days after the initial surgery because 10 days later when they were going to remove the stitches, the patient indicated that the wound was open.Patient suffered due to fever as well approx 3 weeks after the initial surgery.Patient underwent revision surgery, where the implants were extracted and a sample have been sent to the laboratory to determine if the infection was caused by the implants.As per the latest update, patient was still in the hospital (icu).Doctors performed another washing of the wound site because the wound was getting infected.At the wound site, doctors found a bacterium called "large negative germ¿.Also in the blood culture they found a staphylococcus.They did an echocardiogram and it came out negative.The doctor states that it is not certain that the graft is the initial cause of the event.
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