BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL BODY REMOVAL DEVICE

    MDR report key: 1812882 · Received August 12, 2010

    Report

    Report Number
    2249697-2010-01090
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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, "HOOK SNAPPED OFF IN SURGERY DURING TRIAL IMPLANT REMOVAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAL BODY REMOVAL DEVICE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA TCJGB01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention