BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    END CAP 10MM, +4MM

    MDR report key: 1374726 · Received March 4, 2009

    Report

    Report Number
    9610622-2009-00068
    Event Type
    Malfunction
    Date Received
    March 4, 2009
    Date of Event
    February 5, 2009
    Report Date
    February 10, 2009
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032523
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED, AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. SAME PT AS MDR 910622-2009-00069.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA OUR SALES REP, AT THE END OF THE SURGERY, HE HAD PROBLEMS IN TURNING IN THE END CAPS. IT WAS NOT POSSIBLE TO TURN THEM IN. NEVERTHELESS, THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 END CAP 10MM, +4MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K786996

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other