Manufacturing review of the cangaroo envelope device history record could not be completed as the lot/serial number for this event is not known.It is also noted that per the instructions for use (ifu - art-20662) provided with the finished cangaroo envelope device,infection is listed as a potential complication associated with the procedure and device.Although the exact cause of the reported infection cannot be conclusively determined, infection is a known complication associated with the use of a cangaroo envelope and a surgical implant procedure.Should aziyo receive any additional details related to this event, a supplemental report will be filed.
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On 09/18/2020, it was reported by an aziyo sales representative that she had been informed of an infection involving cangaroo envelope (model #: unknown, lot #: unknown) at fort sanders regional hospital.Additional information was received on 10/09/2020 stating that patient returned for follow-up at 6 months post implant with an infection.Initial implant performed utilizing cangaroo envelope hydrated in vancomycin and gentamicin prior to implant (date not reported).Patient was referred to a larger hospital for extraction of the cied device and leads.It was also stated the event was not related to the aziyo device and probably related to the procedure as initial implant procedure lasted approximately 4 hours.Patient was healing and in stable condition.
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