BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D/M ONE-SIDED CABLE TENSIONER

    MDR report key: 1760165 · Received July 12, 2010

    Report

    Report Number
    2249697-2010-00812
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 16, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DR WENT TO USE THE SINGLE SIDED TENSIONER AND IT WOULD NOT GRAB THE CABLE. WE TRIED IT TWICE AND THE TENSIONER DID NOT WORK. THERE WERE ABSOLUTELY NO ADVERSE EFFECTS TO THE PATIENT. WE JUST USED THE OTHER TENSIONER THAT WE HAVE IN THE SET."

    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 68 YR Required Intervention