BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-SERIES METAPHYSEAL MILL GUIDE

    MDR report key: 3883914 · Received June 13, 2014

    Report

    Report Number
    1038671-2014-00279
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    April 28, 2014
    Report Date
    June 10, 2014
    Manufacturer
    EXACTECH, INC.
    Product Code
    HAO
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICES TO THE EXPERIENCE REPORTED COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE DEVICE SPECIFIC IDENTIFICATION INFORMATION WAS NOT PROVIDED, PRECLUDING A REVIEW OF THE DEVICE HISTORY RECORD.

    Description of Event or Problem · 1

    THE ACUMATCH M-SERIES METAPHYSEAL MILL GUIDE WAS PLACED DOWN THE FEMORAL CANAL AND COULD NOT BE EXTRACTED EVEN WITH A HEAVY SLAP HAMMER. AN EXTENDED OSTEOMY WAS PERFORMED IN ORDER TO REMOVE IT. THIS EVENT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351008 M-SERIES METAPHYSEAL MILL GUIDE MILL GUIDE HAO EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R