BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3960131 · Received July 28, 2014

    Report

    Report Number
    0002242816-2014-00059
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 2, 2014
    Manufacturer
    EBI, LLC
    Product Code
    MNI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 PART AND 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. IMPLANTED DATE IS UNKNOWN. FILE TWO OF TWO, SEE 2242816-2014-00058.

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION SURGERY WAS PERFORMED TO REMOVE A BROKEN SCREW. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AND THE FACILITY DISCARDED THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438149 UNKNOWN UNKNOWN MNI EBI, LLC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R