BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYAXIAL DRIVER, REFORM

    MDR report key: 4634913 · Received March 24, 2015

    Report

    Report Number
    3005739886-2015-00034
    Event Type
    Injury
    Date Received
    March 24, 2015
    Date of Event
    December 18, 2014
    Report Date
    March 2, 2015
    Manufacturer
    PRECISION SPINE, INC.
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING EVALUATION OF THE RETURNED DRIVER CONCLUDED THAT THE ROOT CAUSE OF THE FRACTURED TIP IS ATTRIBUTED TO THE DRIVER NOT BEING FULLY SEATED IN THE POLYAXIAL SCREW. THE PLASTIC OUTER SLEEVE OF THE ASSEMBLY WAS PREVIOUSLY MODIFIED TO MITIGATE THE OCCURRENCE OF THE USER UNTHREADING THE OUTER SECURE SHAFT FROM THE TULIP. THIS CHANGE WAS IMPLEMENTED IN MARCH OF 2014. ADDITIONALLY, A DESIGN CHANGE ON THE THREAD-FORM OF THE POLYAXIAL SCREW, HAS BEEN IMPLEMENTED TO REDUCE THE AMOUNT OF THREAD-WASHOUT, THUS REDUCING THE INSERTION TORQUE, TO MITIGATE FAILURES DUE TO THE AFOREMENTIONED CONDITION. REVIEW OF MANUFACTURING HISTORY FOUND A TOTAL OF (B)(4) PIECES OF THIS LOT WERE RELEASED FOR DISTRIBUTION ON NOVEMBER 8, 2014 WITH NO DEVIATION OR ANOMALIES. THIS LOT WAS MANUFACTURED TO A PREVIOUS REVISION OF THE PLASTIC OUTER SLEEVE. DESIGN IMPROVEMENTS HAVE BEEN INITIATED FOR THE SHAFT SLEEVE COMPONENT SUBSEQUENT TO THE MANUFACTURE OF THIS LOT. THIS REPORT IS NUMBER 1 OF 3 MDR'S FILED FOR THE SAME EVENT (REFERENCE 30057398896-2015-00034/36).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A L3-S1 PROCEDURE PERFORMED ON (B)(6) 2014, THE TIP OF TWO REFORM POLYAXIAL DRIVERS (39-SP-0700) BROKE WHILE IMPLANTING THE 7.5 X 45 MM REFORM POLYAXIAL SCREWS. THE SCREWS WERE REMOVED AND REPLACED. NO DELAY TO THE PROCEDURE RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198071 POLYAXIAL DRIVER, REFORM SCREWDRIVER HXX PRECISION SPINE, INC. 3144MMR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention