BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIDENT ACET WINDOW TRIAL 50MM

    MDR report key: 1851410 · Received September 23, 2010

    Report

    Report Number
    2249697-2010-01262
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "WHEN THE SCRUB THREADED THE WINDOW TRIAL ON FOR THE DOCTOR TO TRIAL HIS PREPARED ACETABULUM, THE THREADS WERE CROSS THREADED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT ACET WINDOW TRIAL 50MM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention