BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_OSTEOSYNTHESIS_PRODUCT

    MDR report key: 3002941 · Received March 13, 2013

    Report

    Report Number
    0009610622-2013-00116
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON WAS USING 2 PIECE JIG. BECAUSE THE STRUCTURE IS FLIMSY IT CAUSED THE SURGEON TO MISS WITH THE K-WIRE AND THE LAG SCREW TO THE ANTERIOR WHICH DROVE THE K-WIRE INTO THE NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105718 UNKNOWN_OSTEOSYNTHESIS_PRODUCT INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-KIEL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other