BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOMED MINI COMPRESSION PLATE

    MDR report key: 158087 · Received March 18, 1998

    Report

    Report Number
    2027754-1998-00001
    Event Type
    Injury
    Date Received
    March 18, 1998
    Date of Event
    September 30, 1997
    Report Date
    March 18, 1998
    Manufacturer
    OSTEOMED CORP.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ADMITTED TO SURGERY FOR GLEICH CALCANEAL OSTEOSTOMY. EVANS OPENING WEDGE OSTEOTOMY WITH BONE GRAFT. FUSION OF NAVICULAR CUNEIFORM JOINT WITH BONE GRAFT, AND REPAIR AND PLICATION OF TIBIALIS POSTERIOR TENDON ON 30 SEPT 1997. 3 MONTHS LATER THE PT WAS COMPLAINING OF LOCALIZED PAIN IN THE AREA OF THE PLATE. THE SURGEON WENT BACK INTO THE FOOT 5 MONTHS AFTER THE ORIGINAL SURGERY TO REMOVE THE PLATE. WHICH AT THAT POINT WAS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOMED MINI COMPRESSION PLATE Implant COMPRESSION PLATE HRS OSTEOMED CORP. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R