BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELONGATED PECTUS STABILIZER

    MDR report key: 4850588 · Received June 17, 2015

    Report

    Report Number
    0001032347-2015-00260
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 22, 2015
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK981789
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE WARNINGS IN THE PACKAGE INSERT STATE "FRACTURE, BREAKAGE, MIGRATION, OR LOOSENING OF THE IMPLANT" ARE POSSIBLE ADVERSE EFFECTS. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. FILE TWO OF TWO FOR THE SAME EVENT, SEE ALSO 1032347-2015-00259.

    Description of Event or Problem · 1

    IT IS REPORTED ON (B)(6), 2015 THE PATIENT WAS IMPLANTED WITH A 14 INCH PECTUS BAR AND ONE ELONGATED STABILIZER. THE PATIENT WAS REVISED ON (B)(6), 2015 DUE TO DISLOCATION OF THE PECTUS BAR. DURING THE REVISION THE PATIENT WAS IMPLANTED WITH A 14 INCH PECTUS BAR AND TWO ELONGATED STABILIZERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394026 ELONGATED PECTUS STABILIZER ELONGATED PECTUS STABILIZER HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R