BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFIT BGS PLUG KITS

    MDR report key: 1887011 · Received November 1, 2010

    Report

    Report Number
    1219602-2010-00263
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 30, 2010
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    MQV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. ENDOSCOPY DIV. IS SUBMITTING THE ENCLOSED REPORT TO COMPLY WITH (B)(4) , THE MDR REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY SMITH & NEPHEW INC. ENDOSCOPY DIV. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE OF THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC, ENDOSCOPY DIVISION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC, ENDOSCOPY DIVISION, OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC. ENDOSCOPY DIV., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT.NO PRODUCT BEING RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    PATIENT WHO HAD A TRUFIT PLUG IMPLANTED 4 MONTHS AGO. HE REPORTED THE SURGEON PROBED THE PLUG AND IT SEEMED SOFT, AND ASKED TO SPEAK WITH THE MARKETING MANAGER. THE DOCTOR DOES NOT PLAN ON ANOTHER SCOPE, JUST GOING TO CONSERVATIVELY WATCH HER. HE WAS DOING A KNEE SCOPE ON A PATIENT WHO HAD AN OBI PUT IN ON ONE OF THE PATIENTS CONDYLE SURFACES AND THE OTHER SURFACE HAD A CADAVER PLUG PUT IN. BOTH WERE PUT IN FOUR MONTHS AGO. THE CADAVER GRAFT LOOKED GOOD BUT PATIENT WAS IN LOTS OF PAIN SINCE FIRST SURGERY.

    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