BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 PROBE

    MDR report key: 4121332 · Received September 26, 2014

    Report

    Report Number
    3004024955-2014-00015
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    STRYKER SPINE-US
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT;RESULTS: REVIEW OF THE EVENT DESCRIPTION CONFIRMS THAT THE SURGEON USED THE PROBE INITIALLY TO GAIN ACCESS TO THE PEDICLE AND THEN INSERTED THE K-WIRE. THE XIA 3 SURGICAL TECHNIQUE ADVISES THE USER TO BREAK THROUGH THE CORTICAL BONE USING AN AWL AND TO USE THE PROBE TO PREPARE A PATHWAY THROUGH THE PEDICLE.CONCLUSION: THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS THE USE OF THE PROBE TO BREAK THROUGH THE CORTICAL BONE WITH THE PATIENT'S HARD BONE CONTRIBUTING TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING MANTIS SURGERY, THE SURGEON USED THE CANNULATED PROBE. THE SURGEON ASSEMBLED THE PROBE OF THE OUTER AND INNER AND INSERTED IN THE PATIENT BONE USING THE HAMMER. AFTERWARDS, THE SURGEON INSERTED K-WIRE. WHEN THE SURGEON CHECKED THE X-RAY IMAGE, THE METAL PIECE WAS SEEN IN THE PATIENT BONE. WHEN THE SURGEON CHECKED OUTER PROBE, IT TURNED OUT THAT THE TIP OF OUTER PROBE BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING MANTIS SURGERY, THE SURGEON USED THE CANNULATED PROBE. THE SURGEON ASSEMBLED THE PROBE OF THE OUTER AND INNER AND INSERTED IN THE PATIENT BONE USING THE HAMMER. AFTERWARDS, THE SURGEON INSERTED K-WIRE. WHEN THE SURGEON CHECKED THE X-RAY IMAGE, THE METAL PIECE WAS SEEN IN THE PATIENT BONE. WHEN THE SURGEON CHECKED OUTER PROBE, IT TURNED OUT THAT THE TIP OF OUTER PROBE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601602 XIA 3 PROBE INSTRUMENT-PROBE LXH STRYKER SPINE-US

    Patients

    Seq Age Sex Outcome Treatment
    1