BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-STRATIS

    MDR report key: 936680 · Received October 31, 2007

    Report

    Report Number
    3004824670-2007-00009
    Event Type
    Injury
    Date Received
    October 31, 2007
    Date of Event
    June 26, 2007
    Report Date
    October 31, 2007
    Manufacturer
    SCANDIUS BIOMEDICAL, INC.
    Product Code
    MAI
    PMA / PMN Number
    K04-1961
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT EXPERIENCED A TRAUMATIC EVENT WHILE ENGAGED IN PLAYING BASKETBALL. THIS FOLLOWED SIX (6) MONTHS OF REHABILITATION AFTER THE INITIAL SURGERY. THE SURGEON OBSERVED A FAILURE OF THE GRAFT TO INCORPORATE INTO BONE DURING THE SURGICAL PROCEDURE FOLLOWING THE EVENT. EVALUATION OF THE RETURNED IMPLANT FRAGMENT SHOWED EVIDENCE OF EXTREME LOADING THAT IS CONSISTENT WITH FORCES THAT EXCEED DESIGN LIMITS FOR THIS DEVICE. THE APPARENT LACK OF SOFT TISSUE HEALING, COMBINED WITH EXTREME LOADING CONDITIONS, IS LIKELY TO HAVE CAUSED THE IMPLANT TO FRACTURE. THESE CONDITIONS ARE BEYOND ESTABLISHED LIMITS FOR THE PERFORMANCE OF THE PRODUCT. NOTE: AN INITIAL EVALUATION INDICATED THAT THIS EVENT WAS NOT PRODUCT RELATED. DURING A REVIEW OF COMPLAINT FILES, IT WAS DETERMINED THIS WAS REPORTABLE AS A "SERIOUS INJURY" TYPE EVENT DUE TO A LOW PROBABILITY OF PATIENT INJURY.

    Description of Event or Problem · 1

    THE GRAFT BLOCK IMPLANT BROKE APPROX 6 MONTHS POST-OPERATIVELY WHILE THE PT WAS PLAYING BASKETBALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-STRATIS ABSORBABLE ACL RECONSTRUCTION SYSTEM MAI SCANDIUS BIOMEDICAL, INC. NA 1273

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention