BEUDAMED
    FDA Adverse Event Other Summary report: N

    VILEX HEMI TOE IMPLANT

    MDR report key: 1835726 · Received September 9, 2010

    Report

    Report Number
    1051526-2010-00001
    Event Type
    Other
    Date Received
    September 9, 2010
    Date of Event
    April 23, 2009
    Report Date
    September 8, 2010
    Manufacturer
    MICROCISION, LLC.
    Product Code
    KWD
    PMA / PMN Number
    K023684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR DID NOT CONTACT VILEX AFTER THE THIRD DAY AND NO IMPLANT WAS RETURNED TO VILEX. VILEX WRITES UP EVERY CONCERN REC'D FROM DOCTORS/SURGEONS WHETHER ITS PRODUCT IS AT FAULT OR NOT. VILEX MANAGEMENT TAKES QUALITY MATTERS VERY SERIOUSLY. CUSTOMER SERVICE IS EMPHASIZED AT ALL ASPECTS OF THE COMPANY'S OPERATIONS. IN THE EVENT OF A NON-ROUTINE SURGICAL CASE, A POST-OP PROBLEM OR INCIDENT, VILEX ENDEAVORS TO PUT THE ATTENDING SURGEON IN TOUCH WITH HIGHLY QUALIFIED AND EXPERIENCED PRACTITIONERS WITH A DEPTH OF EXPERIENCE. THESE ADVISORS CONSULT WITH THE ATTENDING SURGEON AND GIVE TECHNICAL ADVICE AND HELP GUIDE THE SURGEON. OFTEN THESE CONSULTATIONS HAVE NOTHING TO DO WITH VILEX OR ITS PRODUCTS AND ARE NOT PART OF ANY SALES EFFORT. THESE CONSULTATIONS CONSTITUTE GOODWILL GESTURES TO THE PROFESSION. IN OTHER WORDS, WHETHER A PT DEVELOPS AN INFECTION THAT VILEX HAS NOTHING TO DO WITH VILEX OR ITS PRODUCT (VILEX MARKETS ONLY METAL IMPLANTS FOR HAND AND FOOT), OR A BROKEN WIRE TIPS, OR HOW BEST TO PERFORM A SPECIFIC SURGERY, VILEX HELPS ITS CUSTOMERS GAIN ADD'L INSIGHT FROM EXPERTS. FOR THE CELLULITIS CASE AT HAND, THE IMPLANT SET WAS STERILIZED AT THE FACILITY AND ALL OF THE DOCTORS VILEX CONSULTED COULD NOT FIND ANY RELATIONSHIP BETWEEN A JOINT IMPLANT AND CELLULITIS. (B)(4).

    Description of Event or Problem · 1

    A VILEX SALES REP REPORTED A CONCERN TO (B)(4), THAT SHE FOLLOWED UP WITH A SURGEON THE DAY AFTER A 1ST MPJ JOINT IMPLANT CASE AND EVERYTHING WENT WELL. THE SECOND DAY AFTER THE CASE THE DOCTOR CONTACTED THE REP TO DELIVER A SET TO ANOTHER FACILITY JUST IN CASE HE WANTED TO REMOVE THE IMPLANT BECAUSE THE PT WAS STILL IN THE HOSPITAL DUE TO HAVING CELLULITIS. (B)(4) FIRST THOUGHT (BEFORE RESEARCHING CELLULITIS) WAS THAT THE METAL OF THE IMPLANT, WIRE (USED AND REMOVED) OR STAPLES (NOT A VILEX PRODUCT) THAT THE DOCTOR USED MIGHT HAVE CAUSED A REACTION DUE TO A NICKEL ALLERGY. (B)(4) CONTACTED TWO DOCTORS (ONE BEING A (B)(4)) TO FIND OUT WHAT COULD CAUSE CELLULITIS AND LEARNED THAT IT IS A BACTERIAL SKIN INFECTION CAUSED WHEN ONE OR MORE TYPES OF BACTERIA ENTER THROUGH A CRACK OR BREAK IN THE SKIN (SUCH AS SURGERY). PER (B)(4), THE SURGEON WAS GIVEN THE NAME OF ANOTHER DOCTOR IN THE AREA WITH VAST SURGICAL EXPERIENCE AND THE SURGEON WAS ASKED TO F/U WITH VILEX CONCERNING THE CONDITION OF THE PT. THE THIRD DAY AFTER THE SURGERY THE DOCTOR WAS CONTACTED AND HE SAID THE INFECTION WAS BETTER, BUT IF THERE WAS PUS PRESENT HE WOULD REMOVE THE IMPLANT. VILEX REC'D NO FURTHER INFO FROM THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VILEX HEMI TOE IMPLANT HEMI IMPLANT KWD MICROCISION, LLC. CHI-3 2513

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization NO INFO.| STAPLES FROM SOME OTHER MFR WAS USED. VILEX HAS