BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE PLATE

    MDR report key: 3111334 · Received May 14, 2013

    Report

    Report Number
    0001032347-2013-00156
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY IS FOREIGN; THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. 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 JOURNAL ARTICLE IDENTIFIES A REVISION SURGERY DUE TO INFECTION AND A PERSISTENT FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213082 BONE PLATE BONE PLATE HRS BIOMET MICROFIXATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization