BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRAX DURATION 26MM X 51MM

    MDR report key: 3940513 · Received July 17, 2014

    Report

    Report Number
    0002249697-2014-02744
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K972792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DISCARDED.

    Additional Manufacturer Narrative · 1

    THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    LINTS OF A WRAPPING NET WERE SCATTERING IN THE PACKAGE. DOCTOR WORRIED ABOUT INFECTION IF THE LINT ENTERED INTO A PATIENT'S BODY.

    Description of Event or Problem · 1

    LINTS OF A WRAPPING NET WERE SCATTERING IN THE PACKAGE. DOCTOR WORRIED ABOUT INFECTION IF THE LINT ENTERED INTO A PATIENT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418850 CENTRAX DURATION 26MM X 51MM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH A12M319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other