BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SBI - SMALL BONE INNOVATIONS

    MDR report key: 1025026 · Received April 1, 2008

    Report

    Report Number
    MW5006126
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    March 31, 2008
    Report Date
    April 1, 2008
    Manufacturer
    SBI
    Product Code
    KWI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SBI RADIAL HEAD LEFT IMPLANT PLACED IN LATE 2007. FOUND TO BE FAILED IMPLANT IN 2008. LOSS OF FIXATION BETWEEN 2 PIECES OF RADIAL HEAD PROSTHESIS. SLID OFF BY ABOUT 50%. COMPLICATION OF PROSTHESIS LOCKING MECHANISM. IN 2008, RADIAL HEAD REPLACEMENT PERFORMED. DATES OF USE: 2007 - 2008. DIAGNOSIS OR REASON FOR USE: FX LEFT RADIAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SBI - SMALL BONE INNOVATIONS RADIAL HEAD KWI SBI 310-0003 38551002
    2 SBI SMALL BONE INNOVATIONS R HEAD LATERAL STEM KWI SBI 310-0010 38555002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PHYSICAL THERAPY PERFORMED AT OUTSIDE SOURCE