BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFORM TERINO MALAR SHELL-MEDIUM

    MDR report key: 2624126 · Received June 18, 2012

    Report

    Report Number
    2028924-2012-00004
    Event Type
    Injury
    Date Received
    June 18, 2012
    Date of Event
    October 6, 2011
    Report Date
    June 8, 2012
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Product Code
    LZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: REVIEWED DEVICE HISTORY RECORDS, STERILIZATION RECORDS, AND PRODUCT LABELING. RESULTS: DEVICE HISTORY RECORDS REVIEW REVEALED NO ASSIGNABLE CAUSE FOR THE REPORTED EVENT. THE STERILIZATION PROCESS WAS WITHIN SPECIFIED PARAMETERS, AND THERE HAVE BEEN NO OTHER REPORTS OF INFECTION INVOLVING THIS STERILE LOT. ((B)(4)).

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT PT EXPERIENCED LEFT CHEEK SWELLING/SOFT TISSUE SWELLING APPROX 3 WEEKS POST-SURGERY AND WAS PLACED ON BIAXIN. LEFT SIDE WAS EXPLANTED APPROX 11 WEEKS POST-SURGERY DUE TO INFECTION. NO CULTURE WAS TAKEN TO IDENTIFY ANY ORGANISM INVOLVED. SOFT TISSUE SWELLING AND EDEMA LESSENED OVER THE NEXT SEVERAL WEEKS. THE LEFT CHEEK IMPLANT WAS REPLACED ON (B)(6) 2012, AND THERE WAS NO EXCESSIVE SWELLING AND TENDERNESS ONLY LASTED 3 DAY POST-SURGERY. PT IS DOING VERY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFORM TERINO MALAR SHELL-MEDIUM MALAR IMPLANT LZK IMPLANTECH ASSOCIATES, INC. NA 840033

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention