BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELASTOSIL T-HANDLE LARGE AO COUPLING

    MDR report key: 1915339 · Received November 17, 2010

    Report

    Report Number
    8031020-2010-00160
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE ADAPTER WILL NOT DISENGAGE THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTOSIL T-HANDLE LARGE AO COUPLING INSTRUMENT LXH STRYKER OSTEOSYNTHESIS SELZACH UNK P25593

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other