BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM TORQUE WRENCH

    MDR report key: 2992540 · Received March 7, 2013

    Report

    Report Number
    0009617544-2013-00064
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 7, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL REPORT. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. NO FURTHER DETAILS OR DATA WERE PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO PRODUCT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT .. "THE TORQUE WRENCH BROKE DURING XIA3 MEDICAL PROCEDURE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE TORQUE WRENCH BROKE DURING XIA3 MEDICAL PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96684 XIA 3 TITANIUM TORQUE WRENCH INSTRUMENT LXH STRYKER SPINE-FRANCE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1