BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-TRITIS

    MDR report key: 996570 · Received February 8, 2008

    Report

    Report Number
    3004824670-2008-00001
    Event Type
    Injury
    Date Received
    February 8, 2008
    Date of Event
    January 7, 2008
    Report Date
    February 6, 2008
    Manufacturer
    SCANDIUS BIOMEDICAL, INC.
    Product Code
    MAI
    PMA / PMN Number
    K06-0522
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACL FIXATION WAS SUCCESSFULLY ACHIEVED FROM THE INITIAL RECONSTRUCTION SURGERY. THE PATIENT REPORTED HAVING PAIN. APPARENTLY, ADEQUATE HEALING HAD OCCURRED, SO THE PHYSICIAN OPTED TO SURGICALLY REMOVE THE IMPLANT WITHOUT ANY NEGATIVE EFFECT ON ACL FIXATION. THE IMPLANT WAS REMOVED, AND IT WAS REPORTED THAT ACL FIXATION WAS MAINTAINED. DESPITE MORE THAN ONE REQUEST FOR FOLLOW UP INFORMATION, ONLY LIMITED PRODUCT INFORMATION, AND NO PATIENT INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. NO PATIENT INJURY WAS REPORTED AS PART OF THIS COMPLAINT, HOWEVER, THIS REPORT IS BEING SUBMITTED AS A "SERIOUS INJURY" EVENT DUE TO THE NEED FOR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    PATIENT COMPLAINED OF PAIN FOLLOWING ACL RECONSTRUCTION SURGERY. THE DEVICE WAS SURGICALLY REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention