BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM

    MDR report key: 7005683 · Received November 7, 2017

    Report

    Report Number
    0009617544-2017-00396
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    October 10, 2017
    Report Date
    January 17, 2018
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWP
    UDI-DI
    07613327002010
    PMA / PMN Number
    K122845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; FINAL TIGHTENING WAS PERFORMED FOR THE SCREW ON THE RIGHT SIDE OF L 4, AFTER TREATMENT FOR THE L 3, COMPRESSION WAS ADDED BASED ON L 4. AT THAT TIME, THE HEAD OF L4 WAS SEPARATED FROM THE HEAD PART AND THE SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; FINAL TIGHTENING WAS PERFORMED FOR THE SCREW ON THE RIGHT SIDE OF L 4, AFTER TREATMENT FOR THE L 3, COMPRESSION WAS ADDED BASED ON L 4. AT THAT TIME, THE HEAD OF L4 WAS SEPARATED FROM THE HEAD PART AND THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785213 ES2 INTEGRATED BLADE SCREW SIZE S 7.5X45MM SPINAL INTERLAMINAL FIXATION ORTHOSIS KWP STRYKER SPINE-FRANCE 482802745 16E143 07613327002010

    Patients

    Seq Age Sex Outcome Treatment
    1