BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD TO ROD COUPLING HOFFMANN II MICRO 3/3MM

    MDR report key: 1983747 · Received January 20, 2011

    Report

    Report Number
    8031020-2011-00016
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 8, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    LXT
    PMA / PMN Number
    K013772
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT UNDERWENT SURGERY WITH THE HOFFMANN MICRO. ON (B)(6) 2011, DURING MONITORING THE PT THE SURGEON FOUND THAT THE FIXATION OF THE ROD COUPLING WAS LOOSE. THE SCREW RAN IDLE WHEN THE SURGEON TIGHTENED THE SCREW FOR THE ROD COUPLING. THE SURGEON CHANGED THE ROD COUPLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROD TO ROD COUPLING HOFFMANN II MICRO 3/3MM IMPLANT LXT STRYKER OSTEOSYNTHESIS SELZACH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other