BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE 300X160MM

    MDR report key: 1905473 · Received November 10, 2010

    Report

    Report Number
    9610622-2010-00479
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 26, 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

    NA.

    Description of Event or Problem · 1

    SALES REP REPORTED THAT THE SURGEON NOTICED WHILE IN SURGERY THAT THE DEVICE HAS A FISSURE AT THE CONNECTION BETWEEN THE METAL AND THE CARBON PART. THE SURGEON WAS ABLE TO FINISH THE SURGERY WITHOUT ANY CONSEQUENCES. HE USED ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET DEVICE 300X160MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KP214193

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other