BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D/M ONE-SIDED CABLE TENSIONER

    MDR report key: 2894328 · Received November 16, 2012

    Report

    Report Number
    2249697-2012-02392
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TENSIONER COULD NOT TENSIONED CABLES. SO, THE SURGEON USED A SPARE PRODUCT INSTEAD OF IT. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D/M ONE-SIDED CABLE TENSIONER INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA TACD501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other