BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HTR-PMI

    MDR report key: 3844573 · Received June 3, 2014

    Report

    Report Number
    0001032347-2014-00189
    Event Type
    Injury
    Date Received
    June 3, 2014
    Report Date
    May 15, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    GXN
    PMA / PMN Number
    PK924935
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIMITED INFORMATION RECEIVED FROM LITERATURE REVIEW. UNKNOWN PATIENT INFORMATION, IMPLANT DETAILS, OR OTHER SURGICAL DETAILS. 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. FILE 1 OF 1.

    Description of Event or Problem · 1

    A PMMA REVISION SURGERY DUE TO PERSISTANT INFECTION WAS REPORTED THROUGH A JOURNAL ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323446 HTR-PMI HARD TISSUE REPLACEMENT GXN BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R