BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFORM POLYAXIAL DRIVER

    MDR report key: 3354612 · Received September 10, 2013

    Report

    Report Number
    3005739886-2013-00029
    Event Type
    Injury
    Date Received
    September 10, 2013
    Date of Event
    August 14, 2013
    Report Date
    August 14, 2013
    Manufacturer
    SPINAL USA, INC
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT INCLUDES TWO (2) FRACTURED DRIVERS FROM THE SAME LOT NUMBER. AS BOTH ARE THE SAME PART NUMBER FROM THE SAME LOT NUMBER, ONLY ONE REPORT IS BEING FILED. EVAL OF THE FRACTURED DRIVERS COULD NOT IDENTIFY THE EXACT ROOT CAUSE, BUT IT IS POSSIBLE THAT THE DRIVER MAY NOT HAVE BEEN COMPLETELY SECURED ONTO THE PEDICLE SCREW. THIS WOULD MINIMIZE THE AMOUNT OF LOAD SHARING INHERENT IN THE DESIGN. WHEN FULLY LOCKED ONTO THE PEDICLE SCREW, THERE IS A SHOULDER WHICH WILL ACT LIKE A FRICTION PLATE ON THE SCREW HEAD, ABSORBING SOME OF THE TORSIONAL STRESSES BEING APPLIED TO THE HEXALOBULAR FITTING. THERE IS ALSO A CROSSBAR ON THE DRIVER WHICH RESIDES IN THE SADDLE, WHICH SHOULD ABSORB SOME OF THE TORSIONAL LOADS. IF THE DRIVER IS NOT SECURELY FASTENED INTO THE PEDICLE SCREW THE HEXALOBULAR FITTING MAY CONSEQUENTLY BE EXPOSED TO EXCESSIVE LOADING SITUATIONS. THE ASSOCIATED REFORM PEDICLE SCREW SYSTEM SURGICAL TECHNIQUE GIVES DETAILED INSTRUCTIONS ON THE PROPER ASSEMBLY OF THE DRIVER TO THE PEDICLE SCREW. IN AN EFFORT TO PREVENT RECURRENCE OF ISSUES OF THIS NATURE, A MATERIAL CHANGE HAS BEEN INITIATED FOR THE DRIVER SHAFT COMPONENT OF THIS INSTRUMENT TO IMPROVE THE STRENGTH AND DURABILITY OF THE HEXALOBULAR TIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A 4 LEVEL POSTERIOR LUMBAR FUSION ON (B)(6) 2013. THE DOCTOR WAS INSERTING THE FINAL POLYAXIAL SCREW AT S-1, WHICH ONLY SEATED ABOUT 3/4 OF THE WAY INTO THE PEDICLE WHEN THE TIP OF THE DRIVER SHEARED OFF IN THE SCREW HEAD. THE DOCTOR WAS ABLE TO REMOVE THE SCREW AND UPON INSERTION OF ANOTHER POLYAXIAL SCREW OF THE SAME SIZE, JUST AS THE SCREW WAS SEATED IN ITS FINAL POSITION, THE TIP OF THE SECOND REFORM POLYAXIAL DRIVER FRACTURED. UPON DISASSEMBLY OF THE DRIVER FROM THE SCREW, THE BROKEN TIP CAME OUT WITH THE DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454551 REFORM POLYAXIAL DRIVER SCREWDRIVER LXH SPINAL USA, INC 3096MM

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R