BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFORM (TM) EXTENDED ANATOMICAL CHIN

    MDR report key: 11886733 · Received May 26, 2021

    Report

    Report Number
    2028924-2021-00001
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    November 4, 2020
    Report Date
    May 26, 2021
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Product Code
    FWP
    UDI-DI
    M724CEACM1
    PMA / PMN Number
    K902825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ACTUAL DEVICE WAS NOT RETURNED, SO IMPLANTECH PERFORMED ANALYSIS OF PRODUCTION RECORDS, INCLUDING STERILIZATION RECORDS, AS WELL AS PERFORMING TREND ANALYSIS. (THERE HAVE BEEN NO OTHER COMPLAINTS OF INFECTION RELATED COMPLICATION ASSOCIATED WITH THE APPLICABLE STERILE LOT.) RESULTS: NO DEVICE PROBLEM WAS FOUND. CONCLUSION: INFECTION IS A KNOWN, INHERENT RISK ASSOCIATED WITH IMPLANT SURGERY, AND IS ADDRESSED IN THE LABELING FOR THE PRODUCT.

    Description of Event or Problem · 1

    COMPLAINANT REPORTED THAT PATIENT PRESENTED WITH ISSUES 8 DAYS AFTER CHIN IMPLANT WAS PLACED INTRAORALLY, AND WAS SUBSEQUENTLY DIAGNOSED WITH AN INFECTION. PATIENT WAS TREATED WITH CIPRO (P.O.) AND DOXYCLYCLIN (P.O.), HOWEVER WHEN RESULTS OF A CULTURE IDENTIFIED STREPTOCOCCUS VIRIDANS, THE AREA WAS DRAINED AND PATIENT WAS SWITCHED TO CLYNDOMYCIN (P.O.) THE PATIENT'S SYMPTOMS DID NOT IMPROVE, AND THE PATIENT HAD THE SITE DRAINED AND NEW COURSES OF CLYNDOMYCIN (P.O.) PRESCRIBED. THE INFECTION IS NOW CONSIDERED TO BE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787305 CONFORM (TM) EXTENDED ANATOMICAL CHIN CHIN IMPLANT FWP IMPLANTECH ASSOCIATES, INC. N/A 889776 M724CEACM1

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention