BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOBLAST II PUTTY, 5CC

    MDR report key: 694594 · Received March 29, 2006

    Report

    Report Number
    2090010-2006-00001
    Event Type
    Injury
    Date Received
    March 29, 2006
    Date of Event
    March 20, 2006
    Report Date
    March 24, 2006
    Manufacturer
    ISOTIS ORTHOBIOLOGICS, INC
    Product Code
    LYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOSPITAL RECEIVED A REPORT THAT A PATIENT WHO HAD CALCANEAL ORIF SURGERY IN JULY 2005 HAS AN ONGOING INFECTION. THE PATIENT WAS IMPLANTED WITH ISOTIS ORTHOBIOLOGICS ORTHOBLAST II PUTTY, 5CC, LOT: 410036/040941 PLUS CANCELLOUS BONE FROM BONE BANK ALLOGRAFTS. INFECTIONS WAS REPORTED AS STAPHYLOCOCCUS (COAGULASE NEGATIVE) AND CORYNEBACTERIUM. PATIENT IS BEING TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHOBLAST II PUTTY, 5CC DEMINERALIZED BONE MATRIX LYC ISOTIS ORTHOBIOLOGICS, INC NA 410036/040941

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention