BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINDER SUBMALAR II FACIAL IMPLANT, MEDIUM

    MDR report key: 2577887 · Received May 10, 2012

    Report

    Report Number
    2028924-2012-00002
    Event Type
    Injury
    Date Received
    May 10, 2012
    Report Date
    May 10, 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 WITH THIS STERILE LOT. (TOTAL OF 142 PRODUCTS.) PRODUCT LABELING ADDRESSES THE POSSIBILITY OF INFECTION.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED AN INFECTION AFTER IMPLANTATION WITH MALAR IMPLANTS. SUBSEQUENTLY, DEVICE WAS EXPLANTED DUE TO THE INFECTION. NO CULTURE WAS TAKEN TO IDENTIFY THE ORGANISM INVOLVED. (IMPLANTECH HAS REQUESTED ADD'L INFO, HOWEVER NO ADD'L INFO HAS BEEN REC'D. THE DEVICE WAS DISTRIBUTED TO PHYSICIAN IN (B)(6) 2012, SO EVENT WOULD HAVE OCCURRED IN 2012.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BINDER SUBMALAR II FACIAL IMPLANT, MEDIUM MALAR IMPLANT LZK IMPLANTECH ASSOCIATES, INC. NA 842502

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention