BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFORM BINDER SUBMALAR, MEDIUM

    MDR report key: 2577892 · Received May 10, 2012

    Report

    Report Number
    2028924-2012-00001
    Event Type
    Injury
    Date Received
    May 10, 2012
    Date of Event
    February 7, 2012
    Report Date
    May 10, 2012
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Product Code
    LZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. (TOTAL OF 945 PRODUCTS.) PRODUCT LABELING ADDRESSES THE POSSIBILITY OF INFECTION.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT PT PRESENTED 12 DAYS AFTER IMPLANTATION WITH MALAR IMPLANTS AND COMPLAINED OF SWELLING AND DRAINAGE ON RIGHT SIDE, AND AN ODD TASTE IN HER MOUTH. A CULTURE WAS TAKEN. PT WAS TREATED WITH ORAL CLINDAMYCIN, THEN SWITCH TO ORAL CIPRO WHEN THE CULTURE CAME BACK POSITIVE FOR ENTEROBACTER AEROGENES. SUBSEQUENTLY, PT REC'D 10 COURSE OF ORAL KEFLEX. PT CONTINUED TO COMPLAIN OF AN ODD TASTE IN HER MOUTH. SIX WEEKS POST-OP, PT WAS ASYMPTOMATIC AND CULTURES WERE NEGATIVE. PT SAW A DENTIST WHO COULD NOT IDENTIFY A PROBLEM. PT SAW AN INFECTIOUS DISEASE SPECIALIST WHO PRESCRIBED A DIFFERENT ANTIBIOTIC, BUT PT DISCONTINUED USE DUE TO STOMACH UPSET. AT TWO MONTHS POST-OP, REPORTING PHYSICIAN FELT PT TO BE ASYMPTOMATIC. PT CONTINUED TO COMPLAIN OF ODD TASTE IN MOUTH, WHICH WAS FELT TO BE POSSIBLE DRAINAGE ALTHOUGH THEY FOUND NO PHYSICAL SIGNS OF DRAINAGE. ON (B)(6) 2012, THE RIGHT SIDE DEVICE WAS EXPLANTED. CULTURE WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFORM BINDER SUBMALAR, MEDIUM MALAR IMPLANT LZK IMPLANTECH ASSOCIATES, INC. NA 606390

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention