BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRITIS IMPLANT 10MM X 30MM BIOABSORB PLA

    MDR report key: 1915721 · Received November 29, 2010

    Report

    Report Number
    3004824670-2010-00003
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    March 14, 2008
    Report Date
    October 26, 2010
    Manufacturer
    SCANDIUS
    Product Code
    MAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MDR REF #: 3004824670-2010-00002 (BIO-STRATIS ST, BIOABSORBABLE, ACL FEMORAL FIXATION IMPLANT).

    Description of Event or Problem · 1

    PROCEDURE: KNEE. ACCORDING TO THE REPORTER: DURING THE RECONSTRUCTIVE SURGERY, THE GUIDE PIN THAT WAS BEING INSERTED BROKE AND THE PATIENT ALLEGEDLY UNDERWENT A SECOND SURGERY TO REMOVE METAL SHAVING. HOWEVER, A 9 INCH PIECE OF THE BROKEN PIN CURRENTLY REMAINS IN HER FEMUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRITIS IMPLANT 10MM X 30MM BIOABSORB PLA SCANDIUS BIOMEDICAL TIBIAL FIX. SYT MAI SCANDIUS 1561

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R