BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MICROFIXATION

    MDR report key: 1344847 · Received March 4, 2009

    Report

    Report Number
    1344847
    Event Type
    Injury
    Date Received
    March 4, 2009
    Date of Event
    February 11, 2009
    Report Date
    February 18, 2009
    Manufacturer
    BIOMET MICROFIXATION, INC.
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2008, PT HAD SURGERY FOR PECTUS EXCAVATUM WITH IMPLANTATION OF BIOMED PECTUS BAR AND MICROFIXATIONS. IN 2009, READMITTED FOR MALPOSITION OF PECTUS BAR, SURGERY WITH REPOSITION OF UPPER PECTUS BAR, THORACIC PLACEMENT OF SECOND 11.5" PECTUS BAR. RIGHT LATERAL STABILIZER BROKEN, LEFT LATERAL STABILIZER TWISTED, DISTORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER MAI BIOMET MICROFIXATION, INC. * 130100

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization