BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOUNTAINEER OCT THORACIC PEDICLE PROBE

    MDR report key: 3213089 · Received July 9, 2013

    Report

    Report Number
    1526439-2013-20729
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO RELATED COMPLAINTS FOR ISSUES OF THIS NATURE, 12 MONTHS TO DATE SUGGESTING THAT THIS IS AN ISOLATED EVENT. WITHOUT A PRODUCT SAMPLE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. NO CORRECTIVE ACTION IS REQUIRED AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE AND THERE HAS BEEN NO OBSERVED SYSTEMIC TREND. THEREFORE, THE COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN INSERTING THE PEDICLE PROBE INTO THE T2 PEDICLE, THE TIP OF THE PROBE BROKE OFF FROM THE INSTRUMENT APPROXIMATELY 40 MM UP THE SHAFT. THE BROKEN PORTION OF THE PROBE WAS RETRIEVED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314414 MOUNTAINEER OCT THORACIC PEDICLE PROBE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE 0205V

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR