BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRE-CONTOURED MESH

    MDR report key: 6028423 · Received October 13, 2016

    Report

    Report Number
    0001032347-2016-00578
    Event Type
    Injury
    Date Received
    October 13, 2016
    Report Date
    September 15, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    GXN
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE PART AND LOT NUMBERS ARE UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED AND 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

    THE COMPANY REPRESENTATIVE REPORTED THAT, "WE ARE ABLE TO START WITH A FEW CASES FOR PRECONTOURED MESHES, WE COULD SEE THE SHAPE GREAT ON DAY 1... AFTER WEEKS TIME WE SEE THE CHANGE IN THE SHAPE." IT WAS REPORTED THAT THE PRODUCT "USED IN( B)(6) HAD NOT HELD ITS CURVATURE AS WELL AS EXPECTED BY THE CUSTOMER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677166 UNKNOWN PRE-CONTOURED MESH CRANIAL MESH GXN BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other