BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R2.0, TI, RIGHT 11X360MM X 125

    MDR report key: 1192799 · Received October 8, 2008

    Report

    Report Number
    9610622-2008-00187
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    JDS
    PMA / PMN Number
    K0334002
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY OUR CUSTOMER TO THE SALES REP. THAT THE NAIL BROKE TWO MONTHS AFTER BEING IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG NAIL KIT R2.0, TI, RIGHT 11X360MM X 125 IMPLANT JDS STRYKER OSTEOSYNTHESIS KIEL NA K552575

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention