BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE 300X160MM

    MDR report key: 1946382 · Received December 10, 2010

    Report

    Report Number
    9610622-2010-00541
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    September 15, 2010
    Report Date
    December 2, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. IF THE DEVICE OR ADD'L INFO BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, GUIDE NOTE BROKEN OFF, ADJUSTMENT OF THE GRADUATION. AN ALTERNATIVE INSTRUMENT WAS NOT AT HAND, AN ADJUSTMENT OF 125 WAS CHOSEN AND "MANUALLY HELD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET DEVICE 300X160MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KME901949

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other