BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM

    MDR report key: 4143438 · Received October 6, 2014

    Report

    Report Number
    0001032347-2014-00346
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    September 10, 2014
    Report Date
    October 2, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK110574
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACKAGE INSERT FOR THIS PRODUCT STATES MIGRATION, BENDING, FRACTURE OR LOOSENING OF THE IMPLANT ARE POSSIBLE ADVERSE EFFECTS. THE USER FACILITY REPORTED THAT THE COMPLAINT ITEM WAS DISCARDED DURING THE REVISION SURGERY AND THEREFORE NOT AVAILABLE FOR REVIEW BY THE MANUFACTURER. THE USER FACILITY REPORTS THAT THE REVISION WAS SUCCESSFUL AND THE PATIENT IS IN STABLE CONDITION. WITHOUT A KNOWN LOT NUMBER, REVIEW OF THE MANUFACTURING RECORDS CANNOT BE PERFORMED. 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 FIVE OF FIVE FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED THE PATIENT EXPERIENCED EXCESSIVE BLEEDING, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM WHERE IT WAS DISCOVERED THAT THE PLATES AND SCREWS HAD LOOSENED FROM THE STERNUM. ALL OF THE PARTS WERE REMOVED AND THE PATIENT IS IN STABLE CONDITION. THE SURGEON EXPRESSED THAT HE BELIEVES THE ISSUE WAS A RESULT OF THE PATIENTS BONE QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622207 BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM SCREW 2.4X16MM CANCELOUS LOCKNG HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R