BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATERAL MANDIBULAR ANGLE(TM)

    MDR report key: 14788930 · Received June 23, 2022

    Report

    Report Number
    2028924-2022-00009
    Event Type
    Injury
    Date Received
    June 23, 2022
    Date of Event
    May 31, 2022
    Report Date
    June 23, 2022
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Product Code
    FWP
    UDI-DI
    M724TMA0410R1
    PMA / PMN Number
    K905268
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    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 HAVE BEEN NO OTHER REPORT COMPLAINTS WITH EITHER THE MANUFACTURING LOT OR ASSOCIATED STERILE LOT. CONCLUSIONS: DISPLACEMENT AND EXTRUSION ARE KNOWN INHERENT RISKS OF IMPLANT PROCEDURES, AND ARE ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    THIS IS THE SAME PATIENT ASSOCIATED WITH MDRS # 2028924-2022-00006 AND 2028924-2022-00010. THIS EVENT IS ASSOCIATED WITH RIGHT SIDE MANDIBULAR ANGLE IMPLANT WHICH WAS EXPLANTED APPROXIMATELY 14 MONTHS POST-OP. THOUGH THE DEVICE MAY HAVE BEEN REMOVED PROPHYLACTICALLY DUE TO INFECTION CONCERNS ON THE DEVICE ASSOCIATED WITH MDR # 2028924-2022-00006, THE PATIENT/COMPLAINANT INDICATED THAT THE SURGEONS WHO REMOVED THE DEVICE HAD INDICATED THAT "EVERYTHING WAS OUT OF PLACE AND THE RIGHT SIDE WAS READY TO TEAR THE MUCOSA AND COME TO THE SURFACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257184 LATERAL MANDIBULAR ANGLE(TM) MANDIBULAR IMPLANT FWP IMPLANTECH ASSOCIATES, INC. N/A 871099 M724TMA0410R1

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Required Intervention TMA-4L/10| TSCI-M