BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D/M ONE-SIDED CABLE TENSIONER

    MDR report key: 2024036 · Received March 11, 2011

    Report

    Report Number
    2249697-2011-00305
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 17, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    NURSE (B)(6) FROM THE CENTRAL STERILIZATION DEPARTMENT REPORT VIA OUR SALES REP, (B)(4), THAT THE TIP OF THE CABLE TENSIONER, WHERE THE CABLE IS GUIDED THROUGH, WAS BENT DURING SURGERY. THEY REPORT MOREOVER THAT THE SURGERY WAS FINISHED WITH AN ALTERNATIVE DEVICE AND THE PATIENT WAS NOT IMPAIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention