BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM, LT ULNA COMPONENT

    MDR report key: 1861942 · Received October 5, 2010

    Report

    Report Number
    2249697-2010-01305
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDC
    PMA / PMN Number
    K980502
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "REVISED AN ULNA COMPONENT BECAUSE IT WAS BROKEN. NO FURTHER DETAILS AVAILABLE, SURGEON TOLD REP HE DID NOT KNOW HOW IT BROKE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM, LT ULNA COMPONENT IMPLANT JDC STRYKER ORTHOPAEDICS MAHWAH NA 65814501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention