BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMBINED SUBMALAR SHELL IMPLANT

    MDR report key: 5073834 · Received September 10, 2015

    Report

    Report Number
    2028924-2015-00005
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    November 3, 2014
    Report Date
    September 9, 2015
    Manufacturer
    IMPLANTECH ASSOCIATES INC.
    Product Code
    LZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DHR REVIEW. LABELING ADDRESSES COMPLICATIONS ASSOCIATED WITH ALL SURGICAL PROCEDURES, INCLUDING POOR WOULD HEALING, HEMATOMA, SEROUS FLUID ACCUMULATION, NERVE DAMAGE OR IRRITATION, NEURALGIA, ETC. RESULTS: ANTICIPATED OR KNOWN.

    Description of Event or Problem · 1

    THIS IS THE SAME PT AND SAME EVENT DESCRIBED IN 2028924-2015-00006. IMPLANTECH HAS ELECTED TO DESCRIBE THIS AS ONE LINKED EVENT, HOWEVER WE ARE SUBMITTING SEPARATE REPORTS TO CAPTURE THE TWO, SEPARATE PRODUCTS INVOLVED IN THIS INCIDENT. COMPLAINANT REPORTS THAT PT WAS IMPLANTED WITH TEAR THROUGH IMPLANTS AND MALAR IMPLANTS BILATERALLY, AND BECAUSE THERE WAS SOME OVERLAP OF THE DEVICES, TITANIUM SCREWS WERE USED TO FIXATE THE DEVICES. APPROXIMATELY 20 DAYS POST IMPLANTATION, PT HAD LEFT INTRAORAL DEHISCENCE, SCREW HAD COME LOOSE, AND MALAR IMPLANT WAS NOT WELL FIXATED. PHYSICIAN REMOVED LEFT SIDE MALAR IMPLANT, CLEANED IT, REINSERTED IT AND REFIXATED THE DEVICE. RIGHT SIDE HAD SMALL POSSIBLE SEROMA AT THAT TIME. TWO WEEKS LATER, THERE WAS AGAIN DEHISCENCE OF LEFT INTRAORAL INCISION, HOWEVER DEVICE WAS IMMOBILE. PHYSICIAN REMOVED LEFT SIDE MALAR IMPLANT, CLEANED AND REINSERTED. SEROMA WAS AGAIN NOTED ON RIGHT SIDE, AND PHYSICIAN REMOVED BOTH RIGHT SIDE IMPLANTS, TRIMMED THEM TO REMOVE OVERLAP, AND REINSERTED THEM. ELEVEN (11) DAYS LATER, CONTINUING PROBLEMS WITH DEHISCENCE LED PHYSICIAN TO REMOVE THE MALAR IMPLANTS BILATERALLY. SEROMA WAS STILL EVIDENT ON RIGHT SIDE, BUT NO PURULENCE WAS NOTED. COMPLAINANT REPORTS THAT PATIENT IS NOW SEEING ANOTHER PHYSICIAN, AND THINKS THE OTHER PHYSICIAN REMOVED THE TEAR THROUGH IMPLANTS BILATERALLY IN (B)(6) 2015 AND PERFORMED A SURGICAL PROCEDURE TO ADDRESS RIGHT SIDE ECTROPIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599294 COMBINED SUBMALAR SHELL IMPLANT MALAR IMPLANT LZK IMPLANTECH ASSOCIATES INC. NA 854905

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention