BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5X4MM HT SD X-DR SCR, EA

    MDR report key: 3103022 · Received May 9, 2013

    Report

    Report Number
    0001032347-2013-00143
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 23, 2013
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK953385
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE USER FACILITY REPORTED THAT THE COMPLAINT ITEM WAS DISCARDED DURING THE REVISION SURGERY AND THEREFORE NOT AVAILABLE FOR REVIEW BY THE MANUFACTURER. 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.

    Description of Event or Problem · 1

    THERE WAS A REVISION SURGERY DUE TO LOOSENING OF THE SCREWS AND PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203234 1.5X4MM HT SD X-DR SCR, EA SCREW JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization