BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG GAMMA NAIL, LEFT 11X380 MM X 130

    MDR report key: 1230497 · Received May 28, 2008

    Report

    Report Number
    9610622-2008-00068
    Event Type
    Injury
    Date Received
    May 28, 2008
    Date of Event
    April 2, 2008
    Report Date
    May 5, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    JDS
    PMA / PMN Number
    K944883
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF THE DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE SURGEON, REPORTED TO THE HOSPITAL RISK MANAGER, THAT THE PRODUCT BROKE IN SITU, SPONTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG GAMMA NAIL, LEFT 11X380 MM X 130 IMPLANT JDS STRYKER OSTEOSYNTHESIS KIEL NA K408236

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention