BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENGTHENER ASSEMBLY HOFFMANN II MICRO

    MDR report key: 2192505 · Received June 30, 2011

    Report

    Report Number
    8031020-2011-00149
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    KTT
    PMA / PMN Number
    K050048
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, AS THE SURGEON ATTEMPTED TO TIGHTEN DOWN THE NUT AT THE TOP OF THE EXTERNAL FIXATOR, THE NUT THAT TIGHTENS UP THE APEX PINS BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LENGTHENER ASSEMBLY HOFFMANN II MICRO IMPLANT KTT STRYKER OSTEOSYNTHESIS SELZACH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other