BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP 3.5 8HO L111 TI

    MDR report key: 2251117 · Received September 13, 2011

    Report

    Report Number
    2520274-2011-00579
    Event Type
    Injury
    Date Received
    September 13, 2011
    Report Date
    August 17, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    DEVICE REPORT RECEIVED FROM (B)(6) INDICATES THE FOLLOWING: PLATE WAS IMPLANTED ON A BROKEN ULNA. AFTER 4.5 MONTHS THE PLATE WAS BROKEN, REPORTEDLY THE PLATE BROKE DUE TO NON UNION. PT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCP 3.5 8HO L111 TI LCP 3.5 8HO L111 TI KTT SYNTHES GMBH 2683706

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS