BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE 300X160MM

    MDR report key: 1071839 · Received July 8, 2008

    Report

    Report Number
    9610622-2008-00111
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    June 10, 2008
    Report Date
    June 16, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED, IT WAS OBSERVED DURING A SURGICAL PROCEDURE THAT THE SURGEON HAD PROBLEMS WITH THE TARGET DEVICE. HE STATED THAT THE DISTAL DRILLING FAILED. FINALLY, HE COMPLETED THE SURGERY BY USING FREEHAND-LOCKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET DEVICE 300X160MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KP237385

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other