BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA II LP MODULAR TAP 5,5MM

    MDR report key: 1760600 · Received July 9, 2010

    Report

    Report Number
    9617544-2010-00258
    Event Type
    Malfunction
    Date Received
    July 9, 2010
    Date of Event
    May 26, 2010
    Report Date
    June 1, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE 5.5 TAP BROKE WHEN INSERTING INTO PEDICLE. DR WAS ABLE TO REMOVE WITH (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA II LP MODULAR TAP 5,5MM INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 066166

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK