BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROPLAST

    MDR report key: 1260675 · Received December 2, 2008

    Report

    Report Number
    MW5009158
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    November 1, 1990
    Report Date
    December 2, 2008
    Manufacturer
    VITEK, INC.
    Product Code
    LZK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    1990: TO CORRECT A PREVIOUS OVERBITE, A LEFORTE I MAXILLARY OSTEOTOMY, GENIOPLASTY AND INSERTION OF "SIX MM PROPLAST HUDROXY APATITE IMPLANTS WERE PLACED IN THE RIGHT AND LEFT INFRAORBITAL RIM AREAS. THE IMPLANTS WERE HELD IN POSITION USING A SINGLE 12MM TITANIUM SCREW ON BOTH THE RIGHT AND LEFT SIDES". THE SURGICAL PROCEDURE WAS PERFORMED BY MEDICAL CENTER, IN 2004 FOR EIGHT MONTHS : AS A RESULT OF SWELLING AROUND THE LEFT EYE, I VISITED ONE OF THE ORIGINAL SURGEONS, WHO INSERTED THE PROPLAST IMPLANTS. THE ORIGINAL SURGEON SAID THERE WAS NOTHING WRONG WITH THE IMPLANT ON THE LEFT SIDE, SAID HE NEVER HAD A PROBLEM WITH THESE TYPE OF IMPLANTS AND SAID I HAD SINUSITUS AND PRESCRIBED AN ANTIBIOTIC. FROM 2004 TO 2007: I EXPERIENCED SEVERE CRANIAL FACIAL PAIN, FATIGUE, CONGESTION, STIFFNESS, SORENESS, LOSS OF HEARING, RASPY VOICE AND SWELLING AROUND THE LEFT AND RIGHT FACIAL CHEEK AREAS. DOCTORS AND HOSPITALS TREATED THE HEADACHES WITH PAIN KILLERS AND TREATED THE CONGESTION WITH ANTIBIOTICS. AS A RESULT OF MY ONGOING PROBLEMS, BEGINNING OF 2004 TO MID 2007, IN 2007 ANOTHER DR, AT THE MEDICAL CENTER REMOVED THE LEFT CHEEK IMPLANT, WHICH WAS COMPLETELY FRAGMENTED. QUOTING FROM DR.OPERATIVE NOTES- "THE WIRE REMOVED WITH THE SCREW AND IT IS TO BE NOTED THAT THE CHEEK IMPLANT HAD A ROD INTO THE BUTTRESS AREA AND THERE SEVERAL HOLES THAT AGAIN WERE NOT ASSOCIATED WITH THE OSTEOTOMY. ALSO, THE MATERIAL HAD SEVERAL VERY SMALL BRANCHES THAT WERE TENUOUS. WE DID OUR BEST TO PRESERVE THESE. THERE WAS VERY LITTLE INTACT NERVE UPON ENTRY. ALSO, IT IS TO BE NOTED THAT WE PREVIOUSLY BEEN TOLD BY CORRESPONDENCE THAT THIS IS A POREX IMPLANT AND TO MY EYE AND CERTAINLY BASED ON MY EXPERIENCE, THIS REPRESENTED A "PROPLAST" IMPLANT. AT THIS POINT, WE METICULOUSLY DEBRIDED THIS DOWN TO THE BONE AND ALSO THE AREAS OF PERFORATION ON THE UNDERSIDE OF THE IMPLANT. THERE WERE AREAS OF BLACKENED TISSUE THAT WERE VERY RUBBERY, INFLAMMATORY AND POSSIBLY FOREIGN BODY GIANT CELL REACTION". IN 2008, DR REMOVED THE RIGHT PROPLAST CHEEK IMPLANT. FOR ELEVEN MONTHS IN 2008: I CONTINUE TO SUFFER FROM THE EFFECTS OF PROPLAST. I UNDERWENT A THIRD INVASIVE SURGERY -SEPTOPLASTY AND TURBINECTOMIES- SIX DAYS LATER RELATED TO MY CRANIAL AND FACIAL HEADACHES THAT ARE RELATED TO THE INSERTION TO PROPLAST INTO MY BODY IN 1990. DATES OF USE: 1990 - 2008. DIAGNOSIS OR REASON FOR USE: AUGMENTATION INFRAORBITAL RIMS LEFT AND RIGHT SIDE. EVENT ABATED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPLAST HUDROXY APATITE -MALAR, BLOCKS, CUSTOM- FACIAL LZK VITEK, INC. MALAR IMPLANTS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| L| O| R| S