BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREADLOCK PLATE, 21 HOLE

    MDR report key: 349307 · Received August 25, 2001

    Report

    Report Number
    9610905-2001-00002
    Event Type
    Injury
    Date Received
    August 25, 2001
    Date of Event
    May 22, 2001
    Report Date
    August 23, 2001
    Manufacturer
    KARL LEIBINGER GMBH U. CO. KG
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A THREADLOCK RIGHT ANGLE PLATE, 21 HOLE (50-195-21) WAS SURGICALLY IMPLANTED IN 2001. SUBSEQUENT TO THAT DATE THE PLATE FRACTURED. THE PLATE WAS REMOVED 8 WEEKS LATER. NO FURTHER COMPLAINTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38822 THREADLOCK PLATE, 21 HOLE PLATE JEY KARL LEIBINGER GMBH U. CO. KG 50-195-21 30039928

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R