BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 HOLE ELONGATE STABILIZER 2PK

    MDR report key: 2073699 · Received May 2, 2011

    Report

    Report Number
    1032347-2011-00058
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    July 19, 2009
    Report Date
    April 4, 2011
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION OF FAILURE FOR THE PECTUS BAR OR STABILIZERS THAT WERE IMPLANTED. THE METHOD OF FIXATION OF THE STABILIZERS (WIRE) IS WHAT FAILED, THEREFORE, THE REVISION SURGERY WAS PERFORMED TO REFIXATE THE STABILIZER. PLEASE SEE MDR #1032347-2011-00059 ALSO, AS THIS IS AN ADDITIONAL REVISION SURGERY FOR THE SAME PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD PECTUS BAR AND STABILIZER IMPLANTED ON (B)(6) 2009 FOR PECTUS CARINATUM. THE STABILIZER WAS FIXATED WITH WIRE. THE WIRE BROKE ON THE RIGHT SIDE, AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 HOLE ELONGATE STABILIZER 2PK STABILIZER HRS BIOMET MICROFIXATION 701630

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization