BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIMIX

    MDR report key: 547634 · Received September 29, 2004

    Report

    Report Number
    1032347-2004-00019
    Event Type
    Other
    Date Received
    September 29, 2004
    Date of Event
    September 7, 2004
    Report Date
    September 7, 2004
    Manufacturer
    BIOMET, INC.
    Product Code
    MBP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD A CALCIUM CEMENT BONE FILTER (POSSIBLY MIMIX) IMPLANTED AT AN EARLIER DATE (UNK) AND THE SKIN OVER THE IMPLANT WAS NOT HEALING AS INTENDED. PT WAS REFERRED TO DR WHO TREATED WITH ANTIBIOTICS FOR MRSA INFECTION. AFTER TREATMENT, DR NOTICED SOME NEW SKIN GROWTH, BUT DECIDED A FLAP WAS NEEDED. WHEN DR PERFORMED THE REVISION SURGERY, HE OBSERVED THREE LAYERS OF THE IMPLANT, WITH TITANIUM MESH BETWEEN TWO OF THE LAYERS AND SOME STAINLESS STEEL WIRE. DR REMOVED SOME OF THE IMPLANT, INCLUDING THE MOST SUPERFICIAL LAYER, BURRED DOWN THE REST TO BE SMOOTH, AND COVERED WITH A FLAP. DEFECT WAS 2-3" X 3-4" IN SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIMIX BONE VOID FILLER MBP BIOMET, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| O