BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW RACK WITH LID VARIAX ELBOW SYSTEM

    MDR report key: 1981654 · Received January 12, 2011

    Report

    Report Number
    8031020-2011-00002
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 15, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    HEADSURGEON REPORTS VIA OUR SALES REP, THAT RESIDUE FROM THE SCREW RACKS WAS ON THE SCREWS. HE FURTHER REPORTS THAT THE SCREWS WERE INTEROPERATIVELY MANUALLY CLEANED AND USED AND THUS THE SURGERY COULD BE FINISHED. SURGEON STATES THAT THIS HAPPENED AFTER AROUND 10 STERILIZATION CYCLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW RACK WITH LID VARIAX ELBOW SYSTEM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS SELZACH NA U16845

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other