BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL NAIL, A/R 9X280 MM

    MDR report key: 2150633 · Received June 23, 2011

    Report

    Report Number
    9610622-2011-00269
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 6, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K010801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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

    THE SURGEON REPORTED VIA THE SALES REP THAT HE OPERATED ON A PT WITH A T2 RETROGRADE FEMORAL NAIL AND THAT ABOUT A WEEK AFTER THE SURGERY, THE PT EXPERIENCED A LOT OF PAIN. HE ADDED THAT THE X-RAYS SHOW THAT THE FEMORAL NAIL BROKE BELOW THE SCREW AND WOULD LIKE TO KNOW HOW THIS COULD HAVE HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL NAIL, A/R 9X280 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K892255

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention