BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFORM BINDER SUBMALAR (R) IMPLANT

    MDR report key: 6062528 · Received October 27, 2016

    Report

    Report Number
    2028924-2016-00001
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    February 11, 2016
    Report Date
    September 7, 2016
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Product Code
    LZK
    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: REVIEWED DEVICE HISTORY RECORDS, STERILIZATION RECORDS, ENVIRONMENTAL MONITORING RECORDS, AND PRODUCT LABELING. ACTUAL DEVICE WAS NOT EVALUATED. RESULTS: THE REVIEWS ABOVE FOUND NO ASSIGNABLE CAUSE FOR THE REPORTED EVENT. THE STERILIZATION PROCESS WAS WITHIN SPECIFIED PARAMETER, AND THERE HAVE BEEN NO OTHER REPORTS OF INFECTION INVOLVING THIS STERILE LOT. ((B)(4)) PRODUCT LABELING ADDRESSES THE POSSIBILITY OF INFECTION. CONCLUSION: THE POSSIBILITY OF INFECTIONS IS A KNOWN, INHERENT RISK ASSOCIATED WITH IMPLANT SURGERY. NOTE: INITIAL REPORT WAS SENT VIA MAIL 09/07/201616 AND IS NOW BEING RESENT 10/25/2016.

    Description of Event or Problem · 1

    COMPLAINANT REPORTED THAT PATIENT'S LEFT SIDE MALAR IMPLANT WAS EXPLANTED APPROXIMATELY 5 MONTHS POST-OPERATIVELY DUE TO INFECTION. APPROXIMATELY 1 MONTH POST-OPERATIVELY, THE PATIENT REPORTED SWELLING CONTINUED FOR A FEW MONTHS EVEN WITH THE USE OF ANTIBIOTICS TO CONTROL THE INFECTION AND PAIN. TESTING PERFORMED AFTER REMOVAL OF THE DEVICE FOUND "HEAVY GROWTH (B)(6)." AT THE TIME OF THIS REPORT, THE INFECTION HAD RESOLVED. DEVICE WAS IMPLANTED AT (B)(6) BUILDING OPERATING ROOM AND WAS EXPLANTED AT THE PHYSICIAN'S OFFICE. PATIENT HAD EAR KELOID EXCISION ON THE SAME DATE AS THE MALAR IMPLANT PLACEMENT. PATIENT HAS PRIOR HISTORY OF (B)(6). ALTHOUGH (B)(6) INFECTIONS ARE OFTEN ASSOCIATED WITH HOSPITALS AND SURGERY CENTERS, AND ARE MORE LIKELY TO OCCUR IN PERSONS WITH COMPROMISED IMMUNE SYSTEMS, IMPLANTECH HAS ELECTED TO REPORT THIS EVENT AS THE REPORTING PHYSICIAN HAS NOT ABSOLVED THE DEVICE FROM CAUSING OR CONTRIBUTING TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713572 CONFORM BINDER SUBMALAR (R) IMPLANT SUBMALAR IMPLANT LZK IMPLANTECH ASSOCIATES, INC. N/A 855034

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention EXCISION OF EAR KELOIDS