BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACU-LOC® VDR PLATE, STD., RIGHT

    MDR report key: 1897538 · Received November 12, 2010

    Report

    Report Number
    3025141-2010-00043
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    August 15, 2008
    Report Date
    October 15, 2010
    Manufacturer
    ACUMED LLC
    Product Code
    HRS
    PMA / PMN Number
    K012655
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    POST PLACEMENT OF AN ACUMED ACU-LOC VDR PLATE, THE PATIENT'S FPL TENDON RUPTURED. THE FPL TENDON WAS REPAIRED AND THE PLATE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACU-LOC® VDR PLATE, STD., RIGHT CONGRUENT BONE PLATE SYSTEM HRS ACUMED LLC PL-DR50R

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention