BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVI XIA MODULAR TAP 5.5MM

    MDR report key: 4642336 · Received March 30, 2015

    Report

    Report Number
    0009617544-2015-00140
    Event Type
    Malfunction
    Date Received
    March 30, 2015
    Date of Event
    March 5, 2015
    Report Date
    March 5, 2015
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    HAW
    PMA / PMN Number
    K012380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER UPDATE :140763. METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: PER THE CORRESPONDENCE IT WAS CONFIRMED THAT THE PATIENT HAD VERY HARD BONE, WHICH RESULTED IN MAKING THE TAP DIFFICULT TO REMOVE. THE TAP WAS THEN REMOVED USING A VICE GRIP THAT WAS IMPACTED. THESE DEVICES SHOULD NOT BE IMPACTED, AS THIS IS NOT THEIR INTENDED USE. CONCLUSION: THE MOST LIKELY CAUSE OF THE CUSTOMER REPORTED EVENT IS THE IMPACTION OF THE DEVICE WITH THE PATIENT'S HARD BONE CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; NAVIGATED TAP INSERTED INTO PEDICLE - 55MM. TAP BECAME STUCK. HAD TO MALLET OUT TAP. TIP OF TAP BROKE OFF IN PEDICLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; NAVIGATED TAP INSERTED INTO PEDICLE - 55MM. TAP BECAME STUCK. HAD TO MALLET OUT TAP. TIP OF TAP BROKE OFF IN PEDICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207934 NAVI XIA MODULAR TAP 5.5MM STEREOTAXIC INSTRUMENT HAW STRYKER SPINE-FRANCE 140763

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR