BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-STRATIS

    MDR report key: 936935 · Received October 31, 2007

    Report

    Report Number
    3004824670-2007-00008
    Event Type
    Other
    Date Received
    October 31, 2007
    Date of Event
    March 21, 2007
    Report Date
    October 31, 2007
    Manufacturer
    SCANDIUS BIOMEDICAL, INC.
    Product Code
    MAI
    PMA / PMN Number
    K04-1961
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO CLINICAL USE OR CLINICAL FAILURE OF THE PRODUCT. IT WAS OBSERVED TO BE DAMAGED IN THE PACKAGE. A REPORT IS BEING FILED AT THIS TIME BASED ON A REVIEW OF COMPLAINT FILES INDICATING THAT PREVIOUS ADVERSE EVENTS HAVE BEEN REPORTED WITH A SIMILAR FAILURE MODE WITHIN THE SAME PRODUCT FAMILY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAFT BLOCK IMPLANT WAS DAMAGED IN THE PACKAGE. THE IMPLANT WAS NOT USED CLINICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-STRATIS ABSORBABLE ACL RECONSTRUCTION SYSTEM MAI SCANDIUS BIOMEDICAL, INC. NA 1128

    Patients

    Seq Age Sex Outcome Treatment
    1 YR