BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE 300X160MM

    MDR report key: 1850337 · Received September 20, 2010

    Report

    Report Number
    9610622-2010-00390
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 5, 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

    ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    NURSE REPORTS VIA OUR SALES REP, THAT HEAD SURGEON EXPERIENCED A MISS DRILLING IN TWO SUCCESSIVE SURGERIES AND THEREFORE, ASKS TO CHECK THE TARGET DEVICE. SHE FURTHER REPORTS THAT THE SURGERIES WERE FINISHED USING THE SAME DEVICE, WHICH WORKED AS INTENDED DURING A SECOND TRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET DEVICE 300X160MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KP267385

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other