BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LPL MEDIAL TIBIA PLATE 9H

    MDR report key: 3832144 · Received May 7, 2014

    Report

    Report Number
    3025141-2014-00067
    Event Type
    Injury
    Date Received
    May 7, 2014
    Report Date
    April 8, 2014
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    PMA / PMN Number
    K033639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING REPORT: A VISUAL EXAMINATION UNDER MAGNIFICATION WAS PERFORMED. THE PLATE SHOWS SCRATCHES ON THE TOP SURFACE, WHICH IS CONSISTENT WITH IMPLANTATION AND REMOVAL AFTER 6 MONTHS. THE FRACTURE OCCURRED IN THE MEDIAL LATERAL PLANE THROUGH THE FOURTH SCREW HOLE FROM THE SUPERIOR END OF THE PLATE. THIS SPLIT THE PLATE INTO A SUPERIOR AND INFERIOR PIECE. EACH PIECE HAS TWO FRACTURES SURFACES SEPARATED BY THE SCREW HOLE. ONE OF THE SURFACES ON BOTH THE INFERIOR AND SUPERIOR PIECES IS SMOOTHER THAN THE OTHER FRACTURE SURFACE IS CONSISTENT WITH SURFACES RUBBING AGAINST ONE ANOTHER. WITHOUT ADD'L INFO NO DEFINITIVE CONCLUSION CAN BE MADE TO WHY THE PLATE BROKE. A CONCLUSION CANNOT BE DRAWN BASED ON THE LACK OF INFO CONCERNING THE CIRCUMSTANCES OF THIS PLATE BREAK. ADD'L MDRS ASSOCIATED WITH THIS EVENT: MDR 3025141-2014-00068: SCREW #1, MDR 3025141-2014-00069: SCREW #2, MDR 3025141-2014-00070: SCREW #3, MDR 3025141-2014-00071: SCREW #4, MDR 3025141-2014-00072: SCREW #5, MDR 3025141-2014-00073: SCREW #6, MDR 3025141-2014-00074: SCREW #7, MDR 3025141-2014-00075: SCREW #8, MDR 3025141-2014-00076: SCREW #9, MDR 3025141-2014-00077: SCREW #10 AND MDR 3025141-2014-00078: SCREW #11.

    Description of Event or Problem · 1

    A FRACTURED TIBIA WAS PLATED WITH A MEDIAL TIBIA PLATE ON (B)(6) 2013. THE PLATE BROKE AND WAS EXPLANTED (ALONG WITH THE SCREWS) ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274835 LPL MEDIAL TIBIA PLATE 9H PLATE, FIXATION, BONE HWC ACUMED LLC 70-0229 258432

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention