BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-STRATIS

    MDR report key: 970892 · Received December 29, 2007

    Report

    Report Number
    3004824670-2007-00014
    Event Type
    Injury
    Date Received
    December 29, 2007
    Date of Event
    November 18, 2007
    Report Date
    December 27, 2007
    Manufacturer
    SCANDIUS BIOMEDICAL, INC.
    Product Code
    MAI
    PMA / PMN Number
    K04-1961
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED IMPLANT FRAGMENTS INDICATED THAT EXTREME LOADING WAS PRESENT AT THE TIME OF FAILURE. IN ADDITION, THE MRI TEST SHOWED EVIDENCE OF A GRAFT TEAR AT THE FEMORAL FIXATION POINT. THIS ALSO PROVIDES EVIDENCE OF EXTREME LOADING CONDITIONS. THE IMPLANT IS DESIGNED TO PROVIDE SUFFICIENT FIXATION FOR A MINIMUM OF 12 WEEKS (3 MONTHS) IN ORDER TO ALLOW FOR THE HEALING PROCESS TO OCCUR. THIS DEVICE FAILED DURING EXERCISE ACTIVITY, 5 MONTHS POST-OPERATIVELY. NO EVIDENCE WAS FOUND TO INDICATE THAT THE PRODUCT FAILED TO PERFORM AS INTENDED. HOWEVER, GIVEN THAT SURGICAL INTERVENTION WAS NEEDED TO REMOVE IMPLANT FRAGMENTS FROM THE JOINT SPACE, THIS IS BEING REPORTED AS A "SERIOUS INJURY" REPORTABLE EVENT.

    Description of Event or Problem · 1

    APPROXIMATELY FIVE (5) MONTHS FOLLOWING ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION, THE PATIENT REPORTED A TRAUMATIC EPISODE WHILE USING EXERCISE EQUIPMENT. MRI CONFIRMED FRACTURE OF THE FIXATION DEVICE (IMPLANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-STRATIS ABSORBABLE ACL RECONSTRUCTION SYSTEM MAI SCANDIUS BIOMEDICAL, INC. NA 1183

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention