BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-STRATIS

    MDR report key: 940668 · Received November 9, 2007

    Report

    Report Number
    3004824670-2007-00011
    Event Type
    Injury
    Date Received
    November 9, 2007
    Date of Event
    September 14, 2007
    Report Date
    November 9, 2007
    Manufacturer
    SCANDIUS BIOMEDICAL, INC.
    Product Code
    MAI
    PMA / PMN Number
    K04-1961
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING ACL RECONSTRUCTION SURGERY, THE CROSS-PIN WAS OVER INSERTED DUE TO USE OF A MALLET. THIS CAUSED THE GRAFT BLOCK IMPLANT TO CRACK. THE FRACTURED IMPLANT WAS REMOVED, AND REPLACED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ALTHOUGH NO PT INJURY WAS REPORTED, A REVIEW OF COMPLAINT FILES INDICATES THAT A LOW PROBABILITY FOR PT INJURY EXISTED. AN MDR IS BEING SUBMITTED AT THIS TIME TO ENSURE FULL COMPLIANCE WITH APPLICABLE REGULATIONS.

    Description of Event or Problem · 1

    GRAFT BLOCK IMPLANT CRACKED INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-STRATIS ABSORBABLE ACL RECONSTRUCTION SYSTEM MAI SCANDIUS BIOMEDICAL, INC. NA 1181

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention