BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCELL CONNEXUS, 1CC

    MDR report key: 669582 · Received January 27, 2006

    Report

    Report Number
    2090010-2005-00004
    Event Type
    Other
    Date Received
    January 27, 2006
    Date of Event
    December 15, 2005
    Report Date
    December 27, 2005
    Manufacturer
    ISOTIS ORTHOBIOLOGICS, INC
    Product Code
    MBO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEROLOGICAL REPORTS WERE REVIEWED FOR THE DONOR BONE USED IN THE ISOTIS PRODUCT. REPORT INDICATES NON-REACTIVE FOR HEPATITIS B AND C. CONTACTED THE TISSUE BANK AND VERIFIED THE REPORT. OBTAINED THE SEROLOGY REPORT FOR THE DONOR OF THE ILIAC CREST WEDGES, ALL TESTS WERE NON-REACTIVE.

    Description of Event or Problem · 1

    PT HAD SPINAL SURGERY IN 2005, IS DOING WELL AND IS ASYMPTOMATIC. PRIMARY CARE PHYSICIAN REPORTED TO ORTHOPEDIC SURGEON THAT THE PT HAS DEVELOPED ANTIBODIES FOR HEPATITIS B AND C. THE ORTHOPEDIC SURGEON REPORTED THIS TO THE TISSUE BANK MGR AT THE HOSP. THE TB MGR CALLED ISOTIS ORTHOBIOLOGICS REQUESTING SEROLOGY REPORTS FOR THE CONNEXUS PRODUCTS USED. TB MGR INFORMED ISOTIS ORTHOBIOLOGICS THAT THE SURGEON ALSO USED 2 ILIAC CREST WEDGES DONATED FROM A SINGLE DONOR IN THIS SURGICAL PROCEDURE. HE HAD ALSO REQUESTED THE SEROLOGICAL REPORTS FROM THE TISSUE BANK THAT SUPPLIED THE ILIAC CREST WEDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCELL CONNEXUS, 1CC DEMINERALIZED BONE MATRIX PRODUCT MBO ISOTIS ORTHOBIOLOGICS, INC CONNEXUS 1CC 510187

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other