BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1865119 · Received October 6, 2010

    Report

    Report Number
    3004485144-2010-00048
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Report Date
    September 16, 2010
    Manufacturer
    LANX, INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT NUMBER: L520010. ADDITIONAL DEVICE MANUFACTURE DATE: (B)(4) 2010. TWO SET SCREW DRIVERS WERE RETURNED FOR EVALUATION. THE RETURNED DRIVERS WERE EVALUATED. THE HEXALOBE TIP OF ONE DRIVER WAS WORN/DAMAGED, BUT IT IS NOT KNOWN IF THIS WAS A CONTRIBUTING FACTOR TO THE EVENT. BOTH DRIVERS FUNCTIONED PROPERLY WHEN ENGAGED WITH A SET SCREW AND TORQUED WITH THE RETURNED TORQUE LIMITING HANDLE. A CAUSE FOR THE ALLEGED DRIVER DISENGAGEMENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    DURING A LUMBAR SPINAL SURGERY, THE SURGEON HAD DIFFICULTY KEEPING THE SET SCREW DRIVER ENGAGED WITH THE TORQUE LIMITING HANDLE. THE ALLEGED PRODUCT PROBLEM DELAYED SURGERY APPROX 20 MINUTES. THE SURGICAL TEAM REPLACED THE DRIVER WITH AN AVAILABLE SPARE AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM KWQ LANX, INC. 7706-1139 L522759

    Patients

    Seq Age Sex Outcome Treatment
    1