BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR

    MDR report key: 6234198 · Received January 9, 2017

    Report

    Report Number
    0009617544-2017-00007
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Date of Event
    December 16, 2016
    Report Date
    April 5, 2017
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    LXH
    UDI-DI
    07613327276855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; NO MANUFACTURING ISSUES WERE FOUND FOR THIS LOT NUMBER. DEVICE WAS NOT RETURNED. THE CAUSE IS NOT DETERMINED AND MULTIFACTORIAL DUE TO NO INSTRUMENT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INNER DRAW ROD ON THE REVISION SCREW DRIVER BROWN DURING A 2 LEVEL HWR WITH ADJACENT LVL ACDF. THE DISTAL TIP OF THE DRIVER BROKE OFF. OTHER SCREWDRIVER WAS USED AND EVERYTHING CAME OUT FINE. NO ADDITIONAL TIME WAS ADDED TO THE CASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INNER DRAW ROD ON THE REVISION SCREW DRIVER BROWN DURING A 2 LEVEL HWR WITH ADJACENT LVL ACDF. THE DISTAL TIP OF THE DRIVER BROKE OFF. OTHER SCREWDRIVER WAS USED AND EVERYTHING CAME OUT FINE. NO ADDITIONAL TIME WAS ADDED TO THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18172 REFLEX HYBRID REVISION DRIVER DRAW ROD SCREW EXTRACTOR OPEDIC MANUAL SURGICAL INSTRUMENT. LXH STRYKER SPINE-FRANCE 14A804 07613327276855

    Patients

    Seq Age Sex Outcome Treatment
    1