BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D/M ONE-SIDED CABLE TENSIONER

    MDR report key: 2945757 · Received January 4, 2013

    Report

    Report Number
    2249697-2013-90042
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 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 EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CABLE COULD NOT BE INSERTED INTO THE SINGLE SIDE TENSIONER WHEN THE SURGEON INSERTED THE CABLE FROM THE TIP OF THE TENSIONER. SO, THE SURGEON USED DOUBLE SIDE TENSIONER INSTEAD OF IT AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5049 D/M ONE-SIDED CABLE TENSIONER INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA TACG306

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other