Manufacturing review of the device history record for the reported lot shows that all units were quality released on 4/25/2019 having met all internal qc acceptance requirements.All sterilization records, and bioburden testing indicate successful sterilization process, and passing lal and product sterility results allowed the lot to be released having met all criteria for manufacturing release.There were no non-conformances associated with the manufacturing lot during production, sterilization and final packaging.In lieu of a request for the oem supplier dhr review, it is noted that aziyo processes the non-sterile envelope materials by cutting, suturing, packaging, and sterilizing.It can be noted that per the instructions for use [ifu] (part number-20663 provided with device) for the cangaroo envelope currently lists infection as a potential complication associated with the procedure and device.Although the exact cause of the reported event cannot be conclusively determined, infection is a known complication with the cangaroo envelope.
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It was reported that the system was removed due to infection with sepsis.Reportedly, necrosis was found after they opened pocket.The physician thought it was an allergic reaction to the device.Pocket area was all black; all necrotic tissue.Subsequently, the physician removed everything (electronic device and cangaroo envelope).
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