BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN DALL MILES TENSIONER

    MDR report key: 6247724 · Received January 12, 2017

    Report

    Report Number
    0002249697-2017-00213
    Event Type
    Malfunction
    Date Received
    January 12, 2017
    Date of Event
    December 24, 2016
    Report Date
    January 12, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DISCARDED.

    Description of Event or Problem · 1

    FRACTURE WHEN INSERTING THE STEM FOR THA TREATMENT. ATTEMPTED TO TREAT BY D-M CABLE, BUT WOULDN'T CROSS INTO THE SINGLE SIDE TENSIONER AND COULDN'T REMOVE THE CABLE FROM THE TENSIONER. INSTEAD CABLE WAS CUT AND ANOTHER CABLE WAS USED TO COMPLETE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30915 UNKNOWN DALL MILES TENSIONER HIP INSTRUMENT KWA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other