BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-STRATIS

    MDR report key: 936679 · Received October 31, 2007

    Report

    Report Number
    3004824670-2007-00007
    Event Type
    Injury
    Date Received
    October 31, 2007
    Date of Event
    November 17, 2005
    Report Date
    October 31, 2007
    Manufacturer
    SCANDIUS BIOMEDICAL, INC.
    Product Code
    MAI
    PMA / PMN Number
    K04-1961
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT HAD SUCCESSFUL ACL RECONSTRUCTIVE SURGERY. AT 2 WEEK POST-OPERATIVE EXAM, THE PHYSICIAN OBSERVED JOINT LAXITY. SUBSEQUENT ARTHROSCOPIC EXAMINATION REVEALED SIGNIFICANT INTRA-SUBSTANCE TEAR OF THE ACL GRAFT, ALONG WITH A FRACTURED GRAFT BLOCK IMPLANT. ANALYSIS OF THE RETURNED IMPLANT FRAGMENT REVEALED EVIDENCE OF EXTREME LOADING CONSISTENT WITH A MAJOR TRAUMATIC EVENT. THIS IS CONSISTENT WITH THE FINDINGS REPORTED BY THE PHYSICIAN. ROOT CAUSE WAS DETERMINED TO BE TRAUMATIC EVENT CAUSED BY ACTIVITIES EXCEEDING THE LIMIT DEFINED IN THE INSTRUCTIONS FOR USE. THIS EVENT WAS INITIALLY DETERMINED TO BE "NOT DEVICE RELATED", HOWEVER, A REVIEW OF THE 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 APPROX 2 WEEKS POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-STRATIS ABSORBABLE ACL RECONSTRUCTION SYSTEM MAI SCANDIUS BIOMEDICAL, INC. NA 1231

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention