BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG GAMMA NAIL, RIGHT 11X340 MM X135

    MDR report key: 1161669 · Received September 15, 2008

    Report

    Report Number
    9610622-2008-00168
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 26, 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
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GAMMA NAIL WAS INSERTED A YEAR AGO. THE NAIL WAS FOUND TO BE BROKEN. A NEW GAMMA 3 NAIL WAS INSERT AND THERE WERE NO OTHER CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG GAMMA NAIL, RIGHT 11X340 MM X135 IMPLANT JDS STRYKER OSTEOSYNTHESIS KIEL NA K651195

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention