BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 5052701 · Received September 1, 2015

    Report

    Report Number
    2028924-2015-00004
    Event Type
    Injury
    Date Received
    September 1, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 31, 2015
    Manufacturer
    IMPLANTECH ASSOCIATES INC.
    Product Code
    FWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    (REVIEWED LABELING FOR IMPLANTECH CHIN IMPLANTS. IMPLANTECH HAS LONG WARNED OF POSSIBILITY OF THE FORMATION OR CONTRACTURE OF FIBROUS TISSUE CAPSULE WHICH MAY RESULT IN PAIN). RESULTS: ANTICIPATED OR KNOWN.

    Description of Event or Problem · 1

    COMPLAINANT REPORTED THAT APPROXIMATELY 15 YEARS POST-IMPLANTATION WITH A CHIN IMPLANT, PT DEVELOPED MILD INTERMITTENT CHIN PAIN. DUE TO THESE SYMPTOMS AND PT DESIRE FOR MORE ANTERIOR CHIN PROJECTION, PT HAD THE CHIN IMPLANT EXPLANTED AND REPLACED WITH ANOTHER DEVICE. A HARD OSSEOUS CAPSULE WAS FOUND AROUND THE IMPLANT. THE REPLACEMENT IMPLANT WAS TRIMMED IN ORDER TO FIT WITHIN EXISTING CAPSULE, WHICH WAS NOT BROKEN UP AND REMOVED. THE COMPLAINANT ACKNOWLEDGED NOT BEING ABLE TO DEFINITIVELY IDENTIFY THE ORIGINAL DEVICE AS AN IMPLANTECH DEVICE, HOWEVER IMPLANTECH HAS ELECTED TO REPORT THIS EVENT IN GOOD FAITH SO THE FDA CAN BE MADE AWARE OF AN EVENT ASSOCIATED WITH CHIN IMPLANTS, REGARDLESS OF THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578853 UNKNOWN UNKNOWN FWP IMPLANTECH ASSOCIATES INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention