BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR HANDLE

    MDR report key: 1981604 · Received January 12, 2011

    Report

    Report Number
    2249697-2010-01929
    Event Type
    Malfunction
    Date Received
    January 12, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 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
    FL, 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

    HANDLE DISCOLORED AND FALLING APART. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR HANDLE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA SBYK05

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention