BEUDAMED
    FDA Adverse Event Injury Summary report: N

    50MM RT STANDARD MAND

    MDR report key: 2942057 · Received February 4, 2013

    Report

    Report Number
    0001032347-2013-00027
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    November 7, 2012
    Report Date
    February 1, 2013
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE USER FACILITY REPORTS THAT THE REVISION WAS SUCCESSFUL AND THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION. WITHOUT A KNOW 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

    THE SALES REPRESENTATIVE REPORTED THE PATIENT HAD A REVISION SURGERY DUE TO A POSSIBLE ALLERGIC REACTION. THE SURGERY FOR REMOVING THE JOINTS WAS PERFORMED (B)(6) 2012. THE PATIENT NAME AND PART NUMBERS WERE IDENTIFIED AND PROVIDED TO BIOMET MICROFIXATION ON (B)(6) 2013, ADDITIONAL MDRS FILED PER RECEIVED PART NUMBERS. SEE ALSO 1032347-2012-00166

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47100 50MM RT STANDARD MAND TMJ LZD BIOMET MICROFIXATION N/A 324090A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization