BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIO LX SMALL CONNECTOR

    MDR report key: 4062537 · Received September 5, 2014

    Report

    Report Number
    0009617544-2014-00390
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWP
    PMA / PMN Number
    K070368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; VISUAL INSPECTION; FUNCTIONAL INSPECTION; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; LABELING REVIEW; ADDITIONAL DOCUMENT REVIEW RESULTS: THE CONNECTOR WAS RECEIVED WITH A JAMMED SET WITH VISIBLY WORN HEX CORNERS. THE WORN NATURE OF THE HEX SUGGESTS THAT THE CORRESPONDING HEX TIP WAS FORCIBLY ROTATED WHILE THE SET SCREW REMAINED STATIONARY, WHICH CONFIRMS THAT THE SET SCREW WAS JAMMED IN THE OFFSET CONNECTOR. NO MANUFACTURING ISSUES WERE IDENTIFIED DURING MANUFACTURING RECORD REVIEW. CONCLUSION: BECAUSE THE RELATED CONNECTOR WAS IMPLANTED IN THE BODY FOR SOME TIME, IT IS HIGHLY LIKELY THAT THE JAMMING IS DUE TO GALLING OF THE CONNECTOR AND BIOLOGICAL PARTICLES LODGED BETWEEN THE OFFSET CONNECTOR AND SET SCREW THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EXTRACTION OF TRIO TRAUMA, A SET SCREW OF CONNECTOR CAN NO LONGER LOOSE IN THE MIDDLE. HOWEVER, IT WAS FINALLY EXTRACTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EXTRACTION OF TRIO TRAUMA, A SET SCREW OF CONNECTOR CAN NO LONGER LOOSE IN THE MIDDLE. HOWEVER IT WAS FINALLY EXTRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544824 TRIO LX SMALL CONNECTOR IMPLANT-CONNECTOR KWP STRYKER SPINE-FRANCE 138792

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR