BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CR TIBIAL INSERT TRIAL #6 -11MM

    MDR report key: 1940990 · Received December 7, 2010

    Report

    Report Number
    2249697-2010-01693
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 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
    SC, 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, "THE TRIAL CRACKED UPON INSERTION. HAD ANOTHER TRAY AVAILABLE AND USED ANOTHER TRIAL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CR TIBIAL INSERT TRIAL #6 -11MM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other