BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCK-NUT

    MDR report key: 2945145 · Received December 26, 2012

    Report

    Report Number
    8030965-2012-01666
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE INVESTIGATION BASED TO THE MANUFACTURING AND MATERIAL DOCUMENTS HAS SHOWN THAT THE COMPLAINED ARTICLES WERE MANUFACTURED ACCORDING TO THE SPECIFICATIONS. ALL METALLIC CONTACTS IN DAMP OR WET CONDITIONS PRODUCE ELECTROLYTIC REACTION WITH CONTACT CORROSION AS RESULT, THAT SHOULD BE AVOIDED. THE RUST RESISTANT APPLIES ONLY IF THE MATERIAL IS STORED UNDER DRY CONDITIONS.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE LOCKING NUTS ARE RUSTY. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCK-NUT LOCKING NUT LXH SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 LOCKING NUT