BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFSET BROACH HANDLE, STD.

    MDR report key: 1905619 · Received November 12, 2010

    Report

    Report Number
    2249697-2010-01530
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 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
    AS
    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

    THE SPRING HAS GONE AND DOES NOT HOLD OR RELEASE THE BROACH. THIS WAS IDENTIFIED DURING THE INTRA OP. ANOTHER IDENTICAL DEVICE WAS IMMEDIATELY AVAILABLE. CASE WAS COMPLETED AS ORIGINALLY PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OFFSET BROACH HANDLE, STD. INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention