BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW

    MDR report key: 3940482 · Received July 17, 2014

    Report

    Report Number
    0001032347-2014-00203
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    March 6, 2008
    Report Date
    June 19, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK001238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    A REVISION WAS PERFORMED DUE TO PAIN, SWELLING, AND CHRONIC MECHANICAL NOISE WITH TINNITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419375 BONE SCREW BONE SCREW JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization