BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELASTOSIL T-HANDLE LARGE AO COUPLING

    MDR report key: 1915338 · Received November 17, 2010

    Report

    Report Number
    9610622-2010-00485
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 28, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA OUR SALES REP, THAT DURING A SURGERY, THE DRILL COULDN'T BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELASTOSIL T-HANDLE LARGE AO COUPLING INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA U13423

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other