BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM

    MDR report key: 4093477 · Received September 16, 2014

    Report

    Report Number
    0001032347-2014-00310
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    June 5, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK953385
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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 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. FILE TWO OF TWO FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THE PLATE WAS IDENTIFIED TO BE FRACTURED IN AN X-RAY. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE PLATE AND SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571578 LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM SCREW JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R