BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINE CRAFT

    MDR report key: 1633055 · Received March 12, 2010

    Report

    Report Number
    MW5015141
    Event Type
    Malfunction
    Date Received
    March 12, 2010
    Date of Event
    March 10, 2010
    Report Date
    March 12, 2010
    Manufacturer
    SPINE CRAFT, LLC
    Product Code
    HWX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ANGLED INTERBODY TAP USED DURING SURGERY. TOP PORTION BROKE OFF AND WAS RETRIEVED BY PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINE CRAFT ANGLED INTERBODY TAP HWX SPINE CRAFT, LLC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR