BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFORM MANDIBULAR ANGLE(TM)

    MDR report key: 14497809 · Received May 25, 2022

    Report

    Report Number
    2028924-2022-00004
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    April 25, 2022
    Report Date
    May 25, 2022
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Product Code
    FWP
    UDI-DI
    M724CMA14L1
    PMA / PMN Number
    K905268
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    METHOD: THE ACTUAL DEVICE WAS NOT EVALUATED, HOWEVER IMPLANTECH REVIEWED PRODUCTION RECORDS, AS WELL AS PERFORMING TREND ANALYSIS. RESULTS: NO DEVICE PROBLEM WAS FOUND. THERE IS ONLY ONE OTHER COMPLAINT ASSOCIATED WITH THIS PRODUCT LOT AND ASSOCIATED STERILE LOT, AND IT INVOLVES THE SAME REPORTING PHYSICIAN. CONCLUSIONS: THE REPORTED EVENTS ARE KNOWN, INHERENT RISK OF IMPLANT PROCEDURES AND ARE ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    COMPLAINANT REPORTS PATIENTS RECEIVED MANDIBULAR ANGLE IMPLANTS BILATERALLY AND SUBSEQUENTLY EXPERIENCED DISPLACEMENT, POOR WOUND HEALING AND PAIN THE LEFT SIDE DEVICE WAS EXPLANTED APPROXIMATELY 11 MONTHS POST-OPERATIVELY. (NOTE: THIS IS THE SAME PATIENT ASSOCIATED WITH REPORT # 2028924-2022-00005. THIS REPORT REPRESENTS THE LEFT SIDE DEVICE. REPORT # 2028924-2022-00005 IS THE REPORT FOR THE RIGHT SIDE DEVICE.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1890739 CONFORM MANDIBULAR ANGLE(TM) MANDIBULAR IMPLANT FWP IMPLANTECH ASSOCIATES, INC. N/A 888511 M724CMA14L1

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Required Intervention