BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRUFIT BGS PLUG

    MDR report key: 1160510 · Received September 12, 2008

    Report

    Report Number
    1651491-2008-00014
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    January 23, 2008
    Report Date
    July 20, 2008
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MQV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INITIAL SURGERY IN 2007 WITH A 9MM PLUG IN THE MFC. PATIENT INITIALLY DID FINE BUT THEN COMPLAINED OF POST-OP PAIN. REVISION SURGERY IN 2008; SITE INSPECTED AND SHOWED DEPRESSION, AND AREA OF INCOMPLETE HEALING. SITE CLEANED OF REMAINING 'CHALKY' MATERIALS. DEFECT WAS NOT FILLED WITH ANY IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFIT BGS PLUG TRUFIT MQV SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention