BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFORM POLYAXIAL DRIVER

    MDR report key: 3404233 · Received September 23, 2013

    Report

    Report Number
    3005739886-2013-00031
    Event Type
    Malfunction
    Date Received
    September 23, 2013
    Date of Event
    August 26, 2013
    Report Date
    August 28, 2013
    Manufacturer
    SPINAL USA, INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT INCLUDES TWO (2) FRACTURED DRIVERS FROM THE SAME LOT NUMBER THEREFORE, ONLY ONE REPORT IS BEING FILED FOR THIS EVENT. PRODUCT EVALUATION IS IN PROCESS. UPON COMPLETION, A FOLLOW-UP MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 IN WHICH TWO 8.5M X 55MM SCREWS FROM A COMPETITOR WERE BEING REMOVED AND REPLACED WITH SPINAL USA, REFORM 8.5MM X 55MM SCREWS. UPON INSERTING THE NEW SCREWS, THE TIP OF TWO REFORM POLYAXIAL DRIVERS SHEARED OFF IN THE SCREW HEAD WHEN THE SCREW WAS SEATED APPROXIMATELY 3/4 OF THE WAY. THE TIPS WERE REMOVED USING A FRAZIER SUCKER TIP AND THE SCREWS WERE SUCCESSFULLY SEATED USING ANOTHER INSTRUMENT THAT WAS READILY AVAILABLE. INFORMATION PROVIDED INDICATES PATIENT HAD VERY HARD BONE. THERE WAS NO SIGNIFICANT DELAY IN PROCEDURE REPORTED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480588 REFORM POLYAXIAL DRIVER SCREWDRIVER LXH SPINAL USA, INC 3096MM

    Patients

    Seq Age Sex Outcome Treatment
    1