BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER SPINE ES2 PEDICLE SCREW

    MDR report key: 9391814 · Received November 27, 2019

    Report

    Report Number
    MW5091354
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    November 26, 2019
    Report Date
    November 26, 2019
    Manufacturer
    STRYKER SPINE
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAD STRYKER ES2 PEDICLE SCREWS PLACED AND TIGHTENED TO SPECIFICS. IN ROOM STRYKER REP CONFIRMED FINAL TIGHTENING. AT 2 MONTHS BEGAN TO HEAR NOISE FROM THE HARDWARE. LOCKING CAP BECAME LOOSE AND HAD TO BE REVISED. ON OPERATING ROOM INSPECTION, CAP NUT HAD BACKED OFF AND HAD SIGNIFICANT WEAR DEBRIS. HARDWARE IN PERFECT POSITION BUT IT FAILED. PAIN INCREASE CORRELATED WITH HEARING SOUNDS FROM PT'S BACK ON LATERAL BENDING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181956 STRYKER SPINE ES2 PEDICLE SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB STRYKER SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R