BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINEWAVE

    MDR report key: 6547934 · Received May 4, 2017

    Report

    Report Number
    6547934
    Event Type
    Injury
    Date Received
    May 4, 2017
    Date of Event
    April 20, 2017
    Report Date
    April 21, 2017
    Manufacturer
    SPINEWAVE
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INTRA-OPERATIVELY THE DISTAL END OF THE SET SCREWDRIVER BROKE OFF AT THE WELDED SITE. ALL PARTS WERE SAFELY REMOVED FROM PATIENT'S BODY. ALL PARTS WERE ACCOUNTED FOR AND XRAY WAS TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324723 SPINEWAVE SCREWDRIVER HXX SPINEWAVE 544J73

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention