BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINDER SUBMALAR (R) IMPLANT

    MDR report key: 6923692 · Received October 6, 2017

    Report

    Report Number
    2028924-2017-00006
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    June 21, 2017
    Report Date
    October 6, 2017
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Product Code
    LZK
    UDI-DI
    M724BSMM1
    PMA / PMN Number
    K894493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: METHOD: THE ACTUAL DEVICE WAS NOT EVALUATED, HOWEVER IMPLANTECH REVIEWED STERILIZATION RECORDS, MANUFACTURING RECORDS, AND PRODUCT LABELING. RESULTS: NO FAILURE WAS DETECTED. CONCLUSION: THE POSSIBILITY OF INFECTION IS A KNOWN, INHERENT RISK ASSOCIATED WITH IMPLANT SURGERY.

    Description of Event or Problem · 1

    COMPLAINANT REPORTED THAT PATIENT COMPLAINED OF LEFT CHEEK TENDERNESS AND HAD LEFT SIDE CHEEK IMPLANT EXPLANTED DUE TO INFECTION APPROXIMATELY 3 MONTHS POST-OPERATIVELY. NO CULTURE WAS TAKEN, SO NO ORGANISM HAS BEEN IDENTIFIED. AS OF (B)(6) 2017, PHYSICIAN FELT INFECTION APPEARS TO BE RESOLVED. NOTE: THE COMPLAINANT REPORTED THAT RHINOPLASTY, NECK LIFT, LIP LIFT, MANDIBLE AND FOREHEAD CONTOURING WITH BROW LIFT AND SCALP ADVANCEMENT WERE CITED AS CONCOMITANT MEDICAL THERAPIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700819 BINDER SUBMALAR (R) IMPLANT MALAR IMPLANT LZK IMPLANTECH ASSOCIATES, INC. N/A 869223 M724BSMM1

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention