BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC NAIL KIT, TI 11X180MM X 130

    MDR report key: 2170047 · Received July 13, 2011

    Report

    Report Number
    9610622-2011-00311
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, PT HAD A NAIL IMPLANTED FOR A FRACTURED HIP. THE NAIL BROKE AT THE LAG SCREW JUNCTION. PT WAS REVISED TO A BIPOLAR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC NAIL KIT, TI 11X180MM X 130 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K127708

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention