BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM

    MDR report key: 6814986 · Received August 23, 2017

    Report

    Report Number
    0009617544-2017-00333
    Event Type
    Malfunction
    Date Received
    August 23, 2017
    Date of Event
    July 28, 2017
    Report Date
    October 27, 2017
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWP
    UDI-DI
    07613327002010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT# 160691. NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED AS ALL UNITS MET STRYKER SPECIFICATIONS. VISUAL AND FUNCTIONAL INSPECTION COULD NOT BE PERFORMED BECAUSE THE DEVICE WAS NOT RETURNED. WITHOUT THE DEVICE EVALUATION, THE EXACT ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TLIF SURGERY, THE SURGEON FELT IDLE OF TORQUE WRENCH WHEN PERFORMING A FINAL TIGHTENING OF THE SCREW OF S1 SEGMENT. THE SCREW HEAD WAS DEVIATED FROM THE SCREW SHAFT WHEN IT WAS EXTRACTED. THE SCREW WAS REPLACED WITH OTHER NEW ONE AND THE SURGERY WAS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TLIF SURGERY, THE SURGEON FELT IDLE OF TORQUE WRENCH WHEN PERFORMING A FINAL TIGHTENING OF THE SCREW OF S1 SEGMENT. THE SCREW HEAD WAS DEVIATED FROM THE SCREW SHAFT WHEN IT WAS EXTRACTED. THE SCREW WAS REPLACED WITH OTHER NEW ONE AND THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594469 ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM SPINAL INTERLAMINAL FIXATION ORTHOSIS. KWP STRYKER SPINE-FRANCE 482802745 160691 07613327002010

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR