BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI 11X180MM X 130

    MDR report key: 1161668 · Received September 15, 2008

    Report

    Report Number
    9610622-2008-00169
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 26, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    JDS
    PMA / PMN Number
    K032244
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED VIA OUR SALES REP, THAT A FEMALE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE NAIL FRACTURING 6 WEEKS POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC NAIL KIT, TI 11X180MM X 130 IMPLANT JDS STRYKER OSTEOSYNTHESIS KIEL NA K453540

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention