BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-STRATIS

    MDR report key: 1019810 · Received March 26, 2008

    Report

    Report Number
    3004824670-2008-00002
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    February 7, 2008
    Report Date
    March 26, 2008
    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

    BASED ON INFO RECEIVED FROM THE SURGEON, WHO PERFORMED BOTH THE INITIAL AND REVISION SURGICAL PROCEDURES, THERE WAS A LACK OF HEALING. THIS, ALONG WITH THE EXCESSIVE LOADING DUE TO PT ACTIVITIES, EXCEEDED THE DESIGN LIMIT FOR THIS DEVICE. THE APPARENT LACK OF SOFT TISSUE HEALING IN COMBINATION WITH HIGH RISK ACTIVITIES IS LIKELY TO HAVE CONTRIBUTED TO THE DEVICE FAILURE. FULL HEALING NORMALLY OCCURS WITHIN THE FIRST 3 MONTHS, FOLLOWING THE INITIAL SURGERY. NO EXPLANATION WAS GIVEN FOR THE LACK OF VISIBLE BONY INGROWTH INTO THE GRAFT AT APPROX 14 MONTHS POST-OPERATIVE.

    Description of Event or Problem · 1

    APPROX 14 MONTHS FOLLOWING ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION, THE PT REPORTED A "GIVE WAY" EPISODE WHILE PLAYING BASKETBALL. MRI AND ENDOSCOPY CONFIRMED FRACTURE OF THE FIXATION DEVICE (IMPLANT). THE DEVICE WAS SURGICALLY REMOVED AND COMPETITIVE PRODUCT WAS USED TO ACHIEVE FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-STRATIS ABSORBABLE ACL RECONSTRUCTION SYSTEM MAI SCANDIUS BIOMEDICAL, INC. NA 1274

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention