BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA II HOOK FORCEPS

    MDR report key: 1350739 · Received January 2, 2009

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    Report

    Report Number
    9617544-2008-00263
    Event Type
    Malfunction
    Date Received
    January 2, 2009
    Date of Event
    November 26, 2008
    Report Date
    November 26, 2008
    Manufacturer
    STRYKER SPINE BORDEUX
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL.

    Description of Event or Problem · 1

    DURING PLF SURGERY, THE HOOK FORCEPS FRACTURED WHEN PLACING THE HOOK TO THE TRAVERSE PROCESS OF THE VERTEBRAE WITH THIS FORCEPS. ANOTHER HOOK FORCEPS WAS AVAILABLE THUS THE SURGEON MANAGED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA II HOOK FORCEPS INSTRUMENT LXH STRYKER SPINE BORDEUX NA 070909

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other