BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUMATCH M-SERIES

    MDR report key: 2860260 · Received November 29, 2012

    Report

    Report Number
    1038671-2012-00144
    Event Type
    Other
    Date Received
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    EXACTECH, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION PENDING RETURN OF DEVICE.

    Description of Event or Problem · 1

    PRIMARY SURGERY ON (B)(6) 2003 WITH IDENTICAL COMPONENTS EXCEPT SMALL METAPHYSEAL. PT WAS SUBSEQUENTLY REVISED ON (B)(6) 2004 (REASON FOR REVISION NOT REPORTED) AND AGAIN IN (B)(6) 2012 DUE TO BROKEN NECK SEGMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUMATCH M-SERIES STRAIGHT STEM LPH EXACTECH, INC. 0414668

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention