BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM

    MDR report key: 2182682 · Received July 5, 2011

    Report

    Report Number
    9617544-2011-00236
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K071373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE, WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, PATIENT WAS HAVING AN L5-S1 FUSION/PLIF/DECOMPRESSION FOR A SPONDY. THE SURGEONS IMPLANTED TWO 7.5X45 XIA REDUX SCREWS AT L5 AND TWO 7.5X40 XIA 3 SCREWS AT S1. THE SURGEONS THEN DID A LAMINECTOMY AND DECOMPRESSION FOLLOWED BY A PLIF USING WEDGENOSE 10X20X4 SPACERS. TO REDUCE THE SPONDY, THE SURGEON INSERTED A 35MM RAD ROD AND ANGLED THE SCREW HEADS AT S1 SO THE RODS HAD TO BE REDUCED IN THE L5 SCREWS. THE BLOCKERS IN THE S1 SCREWS WERE FINAL TIGHTENED WITH THE TORQUE DRIVER AND ANTI-TORQUE KEY. BLOCKERS WERE INSERTED IN THE REDUCTION SCREWS AT L5. THE BLOCKERS WERE ADVANCED BILATERALLY AND SIMULTANEOUSLY BY THE SURGEONS. AS THE ...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM IMPLANT NKB STRYKER SPINE BORDEAUX NA B05450

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR