BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFIT BGS PLUG KITS

    MDR report key: 1316170 · Received December 12, 2008

    Report

    Report Number
    1651491-2008-00033
    Event Type
    Malfunction
    Date Received
    December 12, 2008
    Date of Event
    January 10, 2006
    Report Date
    January 10, 2006
    Manufacturer
    SMITH & NEPHEW INC.
    Product Code
    MQV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE THREE LOT NUMBERS INVOLVED: 011-051011-02, 011-050906-05, 011-050926-01, BUT CANNOT DETERMINE WHICH LOT WAS THE ACTUAL FAILURE IN THIS INCIDENT. AS PART OF OUR RISK MANAGEMENT PROCESS A RETROSPECTIVE REVIEW OF TRUFIT PLUG COMPLAINTS (07/2004 TO 02/2007) WHICH WAS PRIOR TO SMITH-NEPHEW INTEGRATION HAS BEEN CONDUCTED. AS A RESULT THIS COMPLAINT HAS BEEN DETERMINED TO BE REPORTABLE.

    Description of Event or Problem · 1

    THE SURGEON'S PLANNED PROCEDURE TO IMPLANT FOUR PLUGS WAS ABORTED DUE TO THE CAPS COMING OFF. THE SURGEON, IN AN ATTEMPT TO FIX THE DEFECTS, HAD NO MORE PLUGS AVAILABLE. TWO OATS GRAFTS WERE USED TO REPAIR THE ORIGINAL DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFIT BGS PLUG KITS TRUFIT BGS PLUG KITS MQV SMITH & NEPHEW INC. 600-001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1