BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEA SPINE

    MDR report key: 2506198 · Received March 21, 2012

    Report

    Report Number
    MW5024747
    Event Type
    Injury
    Date Received
    March 21, 2012
    Date of Event
    March 20, 2012
    Report Date
    March 21, 2012
    Manufacturer
    S1 SPINE
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TIP OF SCREW DRIVER BROKE OFF INSIDE THE SCREW HEAD DURING REMOVAL OF SCREW. ALL PARTS RECOVERED. USED: SEVERAL HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEA SPINE SCREW DRIVER MAX S1 SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Disability