BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, 4 HOLE SQUARE

    MDR report key: 3946110 · Received July 21, 2014

    Report

    Report Number
    0001032347-2014-00208
    Event Type
    Injury
    Date Received
    July 21, 2014
    Report Date
    June 22, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK011076
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FILE 4 OF 4 : THE SURGEON STATED THE FAILURE RESULTED FROM THE PATIENT'S CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND POOR BONE QUALITY. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT HISTORY OF THE IMPLANTED UNIT 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.

    Description of Event or Problem · 1

    SURGEON REPORTS A PLANNED STERNALOCK REVISION SURGERY DUE TO STERNAL DEHISCENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424378 PLATE, 4 HOLE SQUARE BONE PLATE HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization