BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFIT BGS PLUG KITS

    MDR report key: 1880437 · Received October 22, 2010

    Report

    Report Number
    1219602-2010-00248
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Report Date
    December 1, 2009
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    MQV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) GBU WAS NOTIFIED OF THE INCIDENT IN (B)(4) 2009 HOWEVER THE INFORMATION WAS NOT FORWARDED TO GBU (B)(4) QUALITY UNTIL (B)(4) 2010.(B)(4)

    Description of Event or Problem · 1

    SURGEON FOUND THAT ONE YEAR POST-OP HE CAN SEE THE CARTILAGE LAYER BUT THE HOLE SHOWS NO BONY IN-GROWTH. HE DID A REVISION AND THERE WAS AN AMORPHOUS TISSUE VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFIT BGS PLUG KITS TRUFIT BGS PLUG-BLUE, 9MM MQV SMITH & NEPHEW ENDOSCOPY 72200927 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention