BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCRW,2.4X8MM CANCELOUS LOCKING

    MDR report key: 3131719 · Received May 29, 2013

    Report

    Report Number
    0001032347-2013-00191
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 22, 2013
    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 WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY REPORTED THAT THE COMPLAINT ITEM REMAINS IMPLANTED AND THEREFORE IS 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 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 THE SCREWS BACKING OUT OF THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236306 SCRW,2.4X8MM CANCELOUS LOCKING SCREW HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization