BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-STRATIS

    MDR report key: 940667 · Received November 9, 2007

    Report

    Report Number
    3004824670-2007-00010
    Event Type
    Injury
    Date Received
    November 9, 2007
    Date of Event
    September 19, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING ACL RECONSTRUCTION SURGERY, A CRACK WAS OBSERVED IN THE GRAFT BLOCK IMPLANT. THE FRACTURED IMPLANT WAS REMOVED, AND REPLACED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE RETURNED IMPLANT WAS PHOTOGRAPHED UNDER 23X MAGNIFICATION. THERE WAS EVIDENCE THAT THE IMPLANT FRACTURE WAS CAUSED BY APPLIED STRESS WITHIN THE GRAFT EYE HOLE. THIS IS AN AREA THAT DOES NOT SEE STRESS INTRA-OPERATIVELY. A ROOT CAUSE ANALYSIS WAS PERFORMED BY TESTING SIMILAR PRODUCTS TO DETERMINE WHETHER SURGICAL TECHNIQUE OR MISUSE COULD HAVE BEEN A FACTOR IN THE EVENT. THE RESULT OF THIS INVESTIGATION WAS INCONCLUSIVE. 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 YR Required Intervention