BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ES2

    MDR report key: 3901830 · Received June 24, 2014

    Report

    Report Number
    MW5036876
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 20, 2014
    Manufacturer
    STRYKER SPINE
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE STRYKER LUMBAR TAP PART OF THE THREADS BROKE OFF INTO THE PT'S RIGHT L5 PEDICLE. STRYKER ES2 04.5MM CANNULATED MODULAR TAP (B)(4), (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368856 ES2 STRYKER ES2 04.5MMCANULATED MODU NKB STRYKER SPINE STRYKER ES 2 04.5MMCANULATED

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other